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Tuesday, October 25, 2016

Azelastine Hydrochloride

Class: Antiallergic Agents
VA Class: OP900
Molecular Formula: C₂₂H₂₄ClN₃O•ClH
CAS Number: 79307-93-0
Brands: Astelin, Optivar

Introduction

Relatively selective histamine H₁-receptor antagonist;¹ ² a phthalazinone derivative.¹ ² ¹¹ ¹³ ²¹ ²⁴ ²⁵ ²⁷

Uses for Azelastine Hydrochloride

Seasonal Allergic Rhinitis

Symptomatic treatment of seasonal allergic rhinitis (e.g., hay fever).¹ ¹¹ Intranasal azelastine is at least as effective as oral antihistamines (e.g., cetirizine) or intranasal corticosteroids.¹⁶ ¹⁷ ¹⁸ ¹⁹ ²⁰ ²¹ ²² ²³ ²⁴ ²⁷ ²⁸ May provide improvement of ocular manifestations, possibly secondary to systemic absorption of the drug.¹⁶ ¹⁹ ²¹ ²² ²⁴ ²⁷

Nonallergic Rhinitis

Symptomatic treatment of nonallergic (vasomotor) rhinitis.^a

Allergic Conjunctivitis

Symptomatic relief of ocular itching associated with allergic conjunctivitis.² ³⁰ ³¹

Azelastine Hydrochloride Dosage and Administration

Administration

Administer nasal solution intranasally twice daily, using a spray pump.¹ ¹¹

Apply ophthalmic solution topically to the eye twice daily. ² Ophthalmic solution is not for injection or oral use.²

Intranasal Administration

Before initial use, prime the pump until a fine mist appears, using up to 4 actuations of the pump.¹ ¹¹ ¹⁴ Administration of solution in a stream of liquid rather than as a mist may fail to provide maximum benefit and may cause discomfort.¹⁴

If inhaler has not been used for ≥3 days, reprime pump with 2 actuations or until a fine mist appears.¹⁴ Reprime pump when the spray pump is inserted into the second bottle.¹⁴

To actuate the pump, hold the bottle in one hand, with 2 fingers on the shoulders of the pump unit and the thumb on the bottom of the bottle.¹⁴ Press the bottom firmly and rapidly upward with the thumb to produce a fine mist.¹⁴

Prior to administration, gently blow the nose to clear nasal passages.¹⁴ Insert nasal spray tip ¼ to ½ inch into a nostril, tilt head slightly forward while holding the bottle vertically upright, and aim spray tip toward the back of the nose.¹⁴ Rapidly and firmly press and actuate pump into the nostril while holding the other nostril closed, gently sniffing at the same time;¹⁴ do not tilt head back after dosing.¹⁴

Repeat procedure for the other nostril.¹⁴ Provide a second spray into each nostril, beginning with the first nostril.¹⁴ Alternate nostrils between each actuation of nasal spray.¹⁴

Use caution to avoid spraying nasal spray into the eyes.¹ ¹¹ ¹⁴

Ophthalmic Administration

Remove soft contact lenses prior to administration of each dose (since benzalkonium chloride may be absorbed by the lenses); may reinsert lenses 10 minutes after administration if eyes are not red.²

Avoid contamination of the solution container.²

Dosage

Available as azelastine hydrochloride; dosage expressed in terms of the salt.¹ ² ¹⁴

When properly primed, the nasal spray pump delivers approximately 100 metered doses per bottle.¹ ¹⁶

Pediatric Patients

Seasonal Allergic Rhinitis

Intranasal

Children ≥12 years of age: 2 sprays (274 mcg) in each nostril twice daily.¹ ¹¹ ¹⁶

Children 5–11 years of age: 1 spray (137 mcg) in each nostril twice daily.¹

Nonallergic Rhinitis

Intranasal

Children ≥12 years of age: 2 sprays (274 mcg) in each nostril twice daily.^a

Allergic Conjunctivitis

Ophthalmic

Children ≥3 years of age: 1 drop of a 0.05% solution in the affected eye(s) twice daily.²

Adults

Seasonal Allergic Rhinitis

Intranasal

2 sprays (274 mcg) in each nostril twice daily.¹ ¹¹ ¹⁶

Nonallergic Rhinitis

Intranasal

2 sprays (274 mcg) in each nostril twice daily.^a

Allergic Conjunctivitis

Ophthalmic

1 drop of a 0.05% solution in the affected eye(s) twice daily.²

Special Populations

Geriatric Patients

Cautious dosing of nasal solution recommended.^a

Cautions for Azelastine Hydrochloride

Contraindications

Known hypersensitivity to azelastine or any ingredient in the formulation.^a ^b

Warnings/Precautions

General Precautions

CNS Effects

Somnolence reported in patients receiving azelastine nasal solution.¹ ¹⁶ ¹⁹ ²² ²⁴ ²⁶ ²⁸ Performance of activities requiring mental alertness and physical coordination may be impaired.^a

Concurrent use of nasal solution with other CNS depressants may potentiate CNS depression.^a (See Specific Drugs under Interactions.)

Specific Populations

Pregnancy

Category C.^a ^b

Lactation

Not known whether azelastine is distributed into milk.^a ^b Use with caution in nursing women.^a ^b

Pediatric Use

Safety and efficacy of nasal solution for treatment of seasonal allergic rhinitis not established in children <5 years of age;¹ safety and efficacy for treatment of nonallergic rhinitis not established in children <12 years of age.^a

Safety and efficacy of ophthalmic solution not established in children <3 years of age.²

Geriatric Use

Response to nasal solution does not appear to differ from that in younger adults.^a

No substantial differences in safety and efficacy of ophthalmic solution relative to younger adults.^b

Common Adverse Effects

Nasal solution: Transient nasal burning or stinging,¹⁴ bitter taste, somnolence, headache, pharyngitis, paroxysmal sneezing.¹ ¹⁶ ¹⁹ ²² ²⁴ ²⁶ ²⁸

Ophthalmic solution: Transient ocular burning/stinging, bitter taste, headache.² ³⁰ ³¹

Interactions for Azelastine Hydrochloride

Metabolized by CYP isoenzymes.^a

Specific Drugs

Drug	Interaction	Comments
CNS depressants	Potential additive CNS depression with astelazine nasal solution^a	Avoid concomitant use^a
Cimetidine	Possible increased serum azelastine concentrations^a
Erythromycin	No pharmacokinetic interaction or effect on QT_c observed^a ¹⁶
Ketoconazole	No pharmacokinetic interaction or effect on QT_c observed^a ¹⁶
Ranitidine	No pharmacokinetic interaction observed^a
Theophylline	No pharmacokinetic interaction observed^a

Azelastine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Following intranasal administration, systemic bioavailability is 40%.¹ ¹¹ ¹⁶ Peak plasma concentrations occur 2–3 hours after intranasal administration.^a

Absorption following ophthalmic administration is low.^b

Onset

Following intranasal administration, symptomatic relief is evident within 1 hour; substantial relief usually is apparent within 3 hours; peak effect occurs between 4–6 hours.¹ ¹¹ ¹³

Following ophthalmic administration, onset of action is rapid (3 minutes).²

Duration

Following intranasal administration, effect persists throughout the 12-hour dosage interval.¹ ¹¹ ¹³

Ophthalmic effect persists for about 8 hours.²

Distribution

Plasma Protein Binding

Azelastine: Approximately 88%.^a

N-desmethylazelastine: 97%.^a

Elimination

Metabolism

Metabolized primarily to N-desmethylazelastine (an active metabolite) by CYP isoenzymes.^a

Elimination Route

Approximately 75% of an oral dose is excreted in feces, with <10% as unchanged drug.^a

Half-life

Azelastine: 22 hours (following oral and IV administration).^a

N-desmethylazelastine: 54 hours.^a

Special Populations

In patients with hepatic impairment, pharmacokinetics not altered.^a

Stability

Storage

Nasal

Solution

20–25°C.^a Protect from freezing.^a

Discard both bottles 3 months after initial insertion of the spray pump into the first of the 2 bottles in the dispensing package.¹⁴

Ophthalmic

Solution

20–25°C.^b Store upright.^b

ActionsActions

Inhibits the release of histamine^a and other mediators (e.g., leukotrienes, platelet activating factor [PAF]) involved in allergic reactions.² ²⁹

May inhibit the accumulation of eosinophils at the site of allergic inflammation and prevent eosinophil degranulation.¹ ²⁹

Advice to Patients

Proper techniques for assembly and priming of nasal spray pump and for administration of the nasal solution.¹ Importance of not administering the entire dose (i.e., 4 sprays) into a single nostril.² ¹⁴ Give patients a copy of the manufacturer’s patient instructions.¹ ¹¹ ¹⁴

Importance of learning and adhering to proper administration techniques to avoid contamination of the ophthalmic solution container.²

Importance of removing soft contact lenses prior to administration of each ophthalmic dose.² May reinsert contact lenses 10 minutes after administration if eyes are not red; do not wear contact lenses if eye(s) are red.² Not indicated for contact lens-related irritation.²

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^a

Potential for intranasal azelastine to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.^a Avoid concomitant use of alcohol-containing beverages or products.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a

Importance of informing patients of other important precautionary information.^a (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Azelastine Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.05%	Optivar (with benzalkonium chloride)	MedPointe
Nasal	Solution	0.1% (137 mcg/metered spray)	Astelin Nasal Spray (with benzalkonium chloride)	MedPointe

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Azelastine HCl 0.05% Solution (APOTEX): 6/$95.99 or 18/$259.98

Optivar 0.05% Solution (MEDA PHARMACEUTICALS): 6/$115.99 or 18/$335.95

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Wallace Laboratories. Astelin (azelastine hydrochloride) nasal spray prescribing information. Cranbury, NJ; 2000 Apr.

2. Muro Pharmaceuticals. Optivar (azelastine hydrochloride) ophthalmic solution prescribing information. Tewksbury, MA; 2000 May.

3. Borge PA. Problems in allergic rhinitis. Arzneimittelforschung. 1982; 32:11199-201.

4. Anon. Treatment of seasonal and perennial allergic rhinitis. BMJ. 1981; 283:808-10. [PubMed 6117350]

5. Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy, bronchodilator and antihistaminic products.

6. Douglas WW. Histamine and 5-hydroxytryptamine (serotonin) and their antagonists. In: Gilman AG, Goodman LS, Rall TW et al eds. Goodman and Gilman’s the pharmacologic basis of therapeutics. 7th ed. New York: Macmillan Publishing Company. 1985:605-638.

7. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antihistamine drug products. Final rule. [21 FR Parts 201, 310, 341, 369] Fed Regist. 1992; 57:58356-8.

8. Meltzer EO. To use or not to use antihistamines in patients with asthma. Ann Allergy. 1990; 64:183-6. [IDIS 297019] [PubMed 1967918]

9. Pierson WE, Virant FS. Antihistamines in asthma. Ann Allergy. 1989; 63:601-3. [IDIS 301484] [PubMed 2574551]

10. Simons FER, Simons KJ. The pharmacology and use of H₁-receptor-antagonist drugs. N Engl J Med. 1994; 330:1663-70. [IDIS 330632] [PubMed 7909915]

11. Wallace Laboratories. Product information form for American hospital formulary service: Astelin (azelastine hydrochloride) nasal spray. Cranbury, NJ; 1996 Oct 30.

12. Rimmer SJ, Church MK. The pharmacology and mechanisms of action of histamine H₁-antagonists. Clin Exp Allergy. 1990; 20(Suppl 2):3- 17. [IDIS 364000] [PubMed 1699644]

13. Meltzer EO, Weiler JM, Dockhorn RJ et al. Azelastine nasal spray in the management of seasonal allergic rhinitis. Ann Allergy. 1994; 72:354-9. [IDIS 328847] [PubMed 7908778]

14. Wallace Laboratories. Astelin (azelastine hydrochloride) nasal spray patient information. Cranbury, NJ. 1996 Nov.

15. Weiler JM, Donnelly A, Campbell BH et al. Multicenter double-blind, multiple dose, parallel groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis. J Allergy Clin Immunol. 1988; 82:801-11. [IDIS 316632] [PubMed 3057041]

16. Anon. Azelastine spray for allergic rhinitis. Med Lett Drugs Ther. 1997; 39:45-7. [PubMed 9150688]

17. Pelucchi A, Chiapparino A, Mastropasqua B et al. Effect of intranasal azelastine and beclomethasone dipropionate on nasal symptoms, nasal cytology, and bronchial responsiveness to methacholine in allergic rhinitis in response to grass pollens. J Allergy Clin Immunol. 1995; 95:515-23. [IDIS 342616] [PubMed 7852667]

18. Spaeth J, Schultze V, Klimek L et al. Azelastine reduces histamine- induced swelling of nasal mucosa. ORL J Otorhin Relat Spec. 1996; 58:157-63.

19. LaForce C, Dockhorn RJ, Prenner BM et al. Safety and efficacy of azelastine nasal spray (Astelin NS) for seasonal allergic rhinitis: a 4-week comparative multicenter trial. Ann Allergy Asthma Immunol. 1996; 76:181- 8. [IDIS 364165] [PubMed 8595539]

20. Gastpar H, Nolte D, Aurich R et al. Comparative efficacy of azelastine nasal spray and terfenadine in seasonal and perennial rhinitis. Allergy. 1994; 49:152-8. [PubMed 7911010]

21. Charpin D, Godard P, Garay RP et al. A multicenter clinical study of the efficacy and tolerability of azelastine nasal spray in the treatment of seasonal allergic rhinitis: a comparison with oral cetirizine. Eur Arch Otorhinolaryngol. 1995; 252:455-8. [IDIS 360828] [PubMed 8719584]

22. Ratner PH, Findlay SR, Hampel F et al. A double-blind, controlled trial to assess the safety and efficacy of azelastine nasal spray in seasonal allergic rhinitis. J Allergy Clin Immunol. 1994; 94:818-25. [IDIS 338352] [PubMed 7963150]

23. Weiler JM, Meltzer EO, Benson PM et al. A dose-ranging study of the efficacy and safety of azelastine nasal spray in the treatment of seasonal allergic rhinitis with an acute model. J Allergy Clin Immunol. 1994; 94:972-80. [IDIS 340407] [PubMed 7798545]

24. Passali D, Piragine F. A comparison of azelastine nasal spray and cetirizine tablets in the treatment of allergic rhinitis. J Int Med Res. 1994; 22:17-23. [IDIS 359227] [PubMed 8187941]

25. Ciprandi G, Ricca V, Passalacqua G et al. Seasonal rhinitis and azelastine: long- or short-term treatment? J Allergy Clin Immunol. 1997; 99:301-7.

26. Azelastine-Asthma Study Group. An evaluation of the efficacy and safety of azelastine in patients with chronic asthma. J Allergy Clin Immunol. 1996; 97:1218-24. [PubMed 8648016]

27. Conde Hernandez DJ, Palma Aqilar JL, Delgado Romero J. Comparison of azelastine nasal spray and oral ebastine in treating seasonal allergic rhinitis. Curr Res Med Opin. 1995; 13:299-304.

28. Davies RJ, Bagnall AC, McCabe RN et al. Antihistamines: topical vs oral administration. Clin Exp Allergy. 1996; 26(Suppl 3):11-7. [PubMed 8735853]

29. McNeely W, Wiseman LR. Intranasal azelastine: a review of its efficacy in the management of allergic rhinitis. Drugs. 1998; 56:91-114. [PubMed 9664202]

30. Giede-Tuch C, Westhoff Z, Zarth A. Azelastine eye-drops in seasonal allergic conjunctivitis or rhinoconjunctivitis: a double-blind, randomized, placebo-controlled study. Allergy. 1998; 53:857-62. [PubMed 9788686]

31. Sabbah A, Marzetto M. Azelastine eye drops in the treatment of seasonal allergic conjunctivitis or rhinoconjunctivitis in young children. Curr Med Res Opin. 1998; 14:161-70. [PubMed 9787982]

32. Ciprandi G, Buscaglia S, Cerqueti PM et al. Drug treatment of allergic conjunctivitis: a review of the evidence. Drugs. 1992; 43:154-76. [IDIS 360840] [PubMed 1372215]

33. Morrow GL, Abbott RL. Conjunctivitis. Am Fam Physician. 1998; 57:735-46. [IDIS 418448] [PubMed 9490996]

34. Titi MJ. A critical look at ocular allergy drugs. Am Fam Physician. 1996; 53:2637-42. [IDIS 367250] [PubMed 8644576]

35. Galindez OA, Kaufman HE. Coping with the itchy-burnies: the management of allergic conjunctivitis. Ophthalmology. 1996; 103:1335-6. [IDIS 373485] [PubMed 8841290]

36. Friedlaender MH. Current concepts in ocular allergy. Ann Allergy. 1991; 67:5-10,13. [IDIS 312766] [PubMed 1859041]

37. Trocme SD. Medical therapy for ocular allergy. Mayo Clin Proc. 1992; 67:557-65. [IDIS 296611] [PubMed 1359206]

a. MedPointe. Astelin (azelastine hydrochloride nasal spray) prescribing information. Somerset, NJ; 2000 Aug.

b. MedPointe. Optivar (azelastine hydrochloride ophthalmic solution) 0.05% prescribing information. Tewksbury, MA; 2003 Apr.

More Azelastine Hydrochloride resources

Azelastine Hydrochloride Use in Pregnancy & Breastfeeding
Azelastine Hydrochloride Drug Interactions
Azelastine Hydrochloride Support Group
1 Review for Azelastine Hydrochloride - Add your own review/rating

azelastine ophthalmic Concise Consumer Information (Cerner Multum)

Optivar Prescribing Information (FDA)

Optivar Advanced Consumer (Micromedex) - Includes Dosage Information

Optivar Drops MedFacts Consumer Leaflet (Wolters Kluwer)

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Conjunctivitis, Allergic

Penicilina G Benzatinica Fabra

Penicilina G Benzatinica Fabra may be available in the countries listed below.

Ingredient matches for Penicilina G Benzatinica Fabra

Benzylpenicillin

Benzylpenicillin benzathine (a derivative of Benzylpenicillin) is reported as an ingredient of Penicilina G Benzatinica Fabra in the following countries:

Argentina

International Drug Name Search

Azactam

Generic Name: aztreonam (Intravenous route, Injection route)

az-TREE-oh-nam

Commonly used brand name(s)

In the U.S.

Azactam

Available Dosage Forms:

Powder for Solution

Solution

Therapeutic Class: Antibiotic

Chemical Class: Monobactam

Uses For Azactam

Aztreonam is an antibiotic that is used to treat infections caused by bacteria. It works by killing bacteria or preventing their growth.

Aztreonam is used to treat bacterial infections in many different parts of the body. It is sometimes given with other antibiotics. This medicine will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

Before Using Azactam

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have been done in children and have shown that aztreonam is effective in treating certain bacterial infections and that side effects in children are similar to those experienced by adults. Elevations of liver enzymes and reductions in white blood cell counts were seen in children who were given high doses of this medicine or who had more serious infections.

Geriatric

Aztreonam has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Azactam

To help clear up your infection completely, aztreonam must be given for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, aztreonam must be given on a regular schedule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- Adults and children 16 years of age and older: 1 to 2 grams injected slowly into a vein over a twenty- to sixty-minute period. This is repeated every six to twelve hours.
- Children up to 16 years of age: Dosage is based on body weight and must be determined by your doctor.

Azactam Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

Black, tarry stools

blood in urine or stools

burning or itching of vagina

chest pain

chills

confusion

convulsions (seizures)

cough

dark urine

diarrhea

difficulty in breathing

discharge from vagina

discomfort, inflammation, or swelling at the injection site

dizziness

eye pain

fever

flu-like symptoms

general feeling of illness

headache

hives

light gray-colored stools

loss of appetite

numbness of tongue

pinpoint red spots on skin

seeing double

skin rash, redness, or itching

sore throat

unusual bleeding or bruising

unusual tiredness or weakness

yellow skin or eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

Abdominal or stomach cramps

altered sense of taste

bad breath

breast tenderness

burning or prickling feeling of skin

flushing

increased sweating

mouth ulcers

muscular aches

nasal congestion

nausea or vomiting

ringing, buzzing, or noise in ear

small, nonraised, round, purplish or red spots on skin

sneezing

trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Azactam side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Azactam resources

Azactam Side Effects (in more detail)
Azactam Use in Pregnancy & Breastfeeding
Azactam Drug Interactions
Azactam Support Group
0 Reviews for Azactam - Add your own review/rating

Azactam Prescribing Information (FDA)

Azactam Monograph (AHFS DI)

Azactam MedFacts Consumer Leaflet (Wolters Kluwer)

Aztreonam Prescribing Information (FDA)

Aztreonam Professional Patient Advice (Wolters Kluwer)

Cayston Prescribing Information (FDA)

Cayston Consumer Overview

Cayston MedFacts Consumer Leaflet (Wolters Kluwer)

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Bacteremia
Bacterial Infection
Bone infection
Febrile Neutropenia
Intraabdominal Infection
Kidney Infections
Pelvic Inflammatory Disease
Peritonitis
Pneumonia
Skin and Structure Infection
Skin Infection
Urinary Tract Infection

Abacavir Solution

Pronunciation: a-BAK-a-vir
Generic Name: Abacavir
Brand Name: Ziagen

Abacavir Solution has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough; sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take Abacavir Solution again or take any other medicine that contains abacavir if you have had an allergic reaction to Abacavir Solution. You may be at risk for an even more severe allergic reaction.

Patients who have a certain gene type called HLA-B^*5701 have an increased risk of allergic reaction. A lab test may be performed before you start Abacavir Solution to see if you have this gene type. Discuss any questions or concerns with your doctor.

Abacavir Solution may cause severe and sometimes fatal liver problems or high blood acid levels (lactic acidosis). Contact your doctor right away if you develop yellowing of the skin or eyes; dark urine; pale stools; stomach pain; nausea; vomiting; diarrhea; persistent loss of appetite; fast or difficult breathing; slow or irregular heartbeat; unusual weakness or tiredness; muscle pain or tenderness; unusual feeling of cold (eg, in arms or legs); or unusual drowsiness, dizziness, or lightheadedness.

Abacavir Solution is used for:

Treating HIV infection with other medications.

Abacavir is a nucleoside analog reverse transcriptase inhibitor (NRTI). It works by slowing down the growth of HIV, the virus that causes AIDS.

Do NOT use Abacavir Solution if:

you are allergic to any ingredient in Abacavir Solution

you have had a recent abnormal liver function test or have moderate to severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Abacavir Solution:

Some medical conditions may interact with Abacavir Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding or thinking about breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of heart problems (eg, heart attack), high blood pressure, high cholesterol, diabetes, or smoking

if you have been tested and know whether or not you have a gene type called HLA-B^*5701

Some MEDICINES MAY INTERACT with Abacavir Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Alcohol because it may increase the risk of Abacavir Solution's side effects and toxic effects

Methadone because its effectiveness may be decreased by Abacavir Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abacavir Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Abacavir Solution:

Use Abacavir Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Abacavir Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abacavir Solution refilled.

Abacavir Solution comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking Abacavir Solution.

Take Abacavir Solution by mouth with or without food.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

Taking Abacavir Solution at the same times each day will help you to remember to take it. Continue to take Abacavir Solution even if you feel well. Do not miss any doses.

If you miss a dose of Abacavir Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Abacavir Solution.

Important safety information:

Talk to your doctor before you take Abacavir Solution if you drink more than 3 drinks with alcohol per day.

Tell your doctor or dentist that you take Abacavir Solution before you receive any medical or dental care, emergency care, or surgery.

If you must stop taking Abacavir Solution for any reason other than a serious allergic reaction, do not start taking Abacavir Solution again without talking with your health care provider. If your health care provider decides that you may take Abacavir Solution again, you should do so only in a setting with other people in case you need immediate access to a doctor.

When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Abacavir Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Abacavir Solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.

Abacavir Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.

Abacavir Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.

Lab tests, including liver function tests and monitoring for hypersensitivity reactions, may be performed while you use Abacavir Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Abacavir Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially liver, kidney, or heart problems.

Caution is advised when using Abacavir Solution in CHILDREN; they may be more sensitive to its effects, especially fever; chills; rash; or ear, nose, or throat infection.

Abacavir Solution should not be used in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abacavir Solution while you are pregnant. It is not known if Abacavir Solution is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Abacavir Solution to the baby.

Possible side effects of Abacavir Solution:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; lack of energy; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the skin; change in the amount of urine produced; chest pain or discomfort, numbness of an arm or leg, or sudden vision changes; ear pain; eye pain, redness, or swelling; fainting; fever or chills; general feeling of being unwell; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; muscle pain; unusual cold feeling in the arms or legs; sluggishness; unusual drowsiness, dizziness, or lightheadedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, severe or persistent tiredness); unusual achiness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Abacavir side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Abacavir Solution:

Store Abacavir Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abacavir Solution out of the reach of children and away from pets.

General information:

If you have any questions about Abacavir Solution, please talk with your doctor, pharmacist, or other health care provider.

Abacavir Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Abacavir Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Abacavir resources

Abacavir Side Effects (in more detail)
Abacavir Use in Pregnancy & Breastfeeding
Abacavir Drug Interactions
Abacavir Support Group
0 Reviews for Abacavir - Add your own review/rating

Compare Abacavir with other medications

HIV Infection
Nonoccupational Exposure

Hydromorphone Extended-Release Capsules

Generic Name: Hydromorphone (hye-droe-MOR-fone)
Brand Name: Palladone

Hydromorphone Extended-Release Capsules are only for adults with constant (around-the-clock) pain that is moderate to severe and expected to last for weeks or longer. It should only be used by patients who are narcotic tolerant and already using other narcotic medicines. Hydromorphone Extended-Release Capsules are not for occasional or "as-needed" use and it should not be the first narcotic pain medicine prescribed for your pain. Hydromorphone Extended-Release Capsules are not for patients who need narcotic pain medicine for a short time. Use in non-narcotic-tolerant patients could be life-threatening. Overestimating the dose of Hydromorphone Extended-Release Capsules when switching from another narcotic can cause death by overdose on the first dose. Patients who receive an overdose will need to be monitored for at least 18 hours. Hydromorphone Extended-Release Capsules also has a high risk for abuse. Mental illness and personal or family history of substance abuse increase this risk. Patients should be assessed for risks of abuse and monitored throughout the treatment for signs of misuse, abuse, or addiction. Do not break, crush, dissolve, chew, or open the capsule. If all of the medicine is released in your body at once, you could experience very serious side effects, including death from overdose. The capsule must be swallowed whole. Hydromorphone Extended-Release Capsules can cause serious side effects, including breathing problems that can lead to death, if it is used the wrong way.

Hydromorphone Extended-Release Capsules are used for:

Treating pain in adults with constant (around-the-clock) moderate to severe pain that is expected to last for an extended period of time. Hydromorphone Extended-Release Capsules should only be started after you have been taking other narcotic (opioid) medicines and your body has gotten used to them (opioid tolerant). Hydromorphone Extended-Release Capsules are not for use as the first narcotic pain medicine prescribed for you, for short-term use, or for occasional ("as-needed") use.

Hydromorphone Extended-Release Capsules are an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system used by the body's natural "pain relievers."

Do NOT use Hydromorphone Extended-Release Capsules if:

you are allergic to any ingredient in Hydromorphone Extended-Release Capsules or any other morphine-related medicine (eg, morphine, codeine, oxycodone)

you have diarrhea associated with poisoning, antibiotic use, a bacterial infection (from eating or drinking contaminated food or water); a stomach problem called paralytic ileus (loss of strength in the intestinal muscles)

you have acute (sudden) or severe asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), shallow breathing, emphysema, right-sided heart failure, or a brain injury or disease with increased pressure in the brain

you are taking cimetidine or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hydromorphone Extended-Release Capsules:

Some medical conditions may interact with Hydromorphone Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have or have ever had alcoholism, substance abuse, or narcotic dependence; if you consume more than 3 alcoholic drinks per day; or if you have a family history of these problems

if you have considered or attempted suicide; or if you have major depression or hallucinations (seeing or hearing things that are not there)

if you have an acute head injury, increased pressure in the head, brain injury or tumor, epilepsy, or seizures (convulsions)

if you have an acute stomach or intestinal problem; chronic inflammation and ulceration of the bowel; low blood volume; recent abdominal surgery; adrenal gland problems; enlargement of the prostate gland; gallbladder problems; heart failure; lung disease, including shortness of breath; kidney or liver problems; low blood pressure; underactive thyroid; or urinary blockage or problems urinating

Some MEDICINES MAY INTERACT with Hydromorphone Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturate anesthetics (eg, thiopental), cimetidine, ketorolac, muscle relaxants (eg, cyclobenzaprine), phenothiazines (eg, thioridazine), sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur

Risperidone, rifamycins (eg, rifampin), or certain pain relievers because effectiveness of Hydromorphone Extended-Release Capsules may be decreased

Naltrexone because the effectiveness of Hydromorphone Extended-Release Capsules will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids

Mexiletine because effectiveness may be decreased by Hydromorphone Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydromorphone Extended-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hydromorphone Extended-Release Capsules:

Use Hydromorphone Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Hydromorphone Extended-Release Capsules comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Hydromorphone Extended-Release Capsules refilled.

Hydromorphone Extended-Release Capsules may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

This capsule must be swallowed whole with water. If you cannot swallow the capsule whole, contact your doctor. Do not break, chew, dissolve, crush, or open the capsule before swallowing. Taking a broken, chewed, dissolved, or crushed capsule or its contents can release the full 24-hour dose into your body all at once. This is very dangerous. You could die from an overdose of the medicine.

If you miss a dose of Hydromorphone Extended-Release Capsules, take it as soon as possible. Take your next dose 24 hours later. Do not double your prescribed dose of Hydromorphone Extended-Release Capsules at any time because this increases your chance of an overdose. If you are not sure what to do or you miss more than one dose, contact your doctor.

Ask your health care provider any questions you may have about how to use Hydromorphone Extended-Release Capsules.

Important safety information:

Hydromorphone Extended-Release Capsules may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Hydromorphone Extended-Release Capsules. Using Hydromorphone Extended-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Hydromorphone Extended-Release Capsules. Hydromorphone Extended-Release Capsules will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Hydromorphone Extended-Release Capsules may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit or stand up slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

Do not drink alcohol while you are using Hydromorphone Extended-Release Capsules.

Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.

If you continue to have pain, your pain worsens, or you have side effects that concern you, contact your health care provider immediately.

Constipation is a common side effect of Hydromorphone Extended-Release Capsules. Talk to your health care provider about using laxatives or stool softeners to prevent or treat constipation while taking Hydromorphone Extended-Release Capsules.

Before you have any medical or dental surgery or emergency treatment, tell the doctor or dentist that you are taking Hydromorphone Extended-Release Capsules.

Use Hydromorphone Extended-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects, especially the possible decreased breathing and drowsiness effects.

Hydromorphone Extended-Release Capsules are not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Hydromorphone Extended-Release Capsules during pregnancy. Hydromorphone Extended-Release Capsules are excreted in breast milk. Do not breast-feed while taking Hydromorphone Extended-Release Capsules.

Use of Hydromorphone Extended-Release Capsules can lead to TOLERANCE. When using for an extended period, Hydromorphone Extended-Release Capsules may not work as well and may require different dosing. Talk with your doctor if Hydromorphone Extended-Release Capsules stops working well.

Long-term use of Hydromorphone Extended-Release Capsules can lead to physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness pain where pain comfort is more important. If using Hydromorphone Extended-Release Capsules for an extended period of time, do not suddenly stop taking Hydromorphone Extended-Release Capsules without your doctor's approval. WITHDRAWAL symptoms have occurred when Hydromorphone Extended-Release Capsules are suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact you doctor if you notice any of these symptoms after stopping this medication.

Possible side effects of Hydromorphone Extended-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; drowsiness; dry mouth; general body discomfort; headache; infection; itching; sleepiness; sweating; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; feeling faint or dizzy; hallucinations; pounding in the chest; seizure; shallow breathing; urination problems; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Hydromorphone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizure (convulsions).

Proper storage of Hydromorphone Extended-Release Capsules:

Store Hydromorphone Extended-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hydromorphone Extended-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Hydromorphone Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

Hydromorphone Extended-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hydromorphone Extended-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Hydromorphone resources

Hydromorphone Side Effects (in more detail)
Hydromorphone Use in Pregnancy & Breastfeeding
Drug Images
Hydromorphone Drug Interactions
Hydromorphone Support Group
165 Reviews for Hydromorphone - Add your own review/rating

Compare Hydromorphone with other medications

Anesthetic Adjunct
Cough
Pain

Abilify Discmelt

Generic Name: aripiprazole (Oral route)

ar-i-PIP-ra-zole

Oral route(Tablet;Tablet, Disintegrating;Solution)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients with depression .

Commonly used brand name(s)

In the U.S.

Abilify

Abilify Discmelt

Available Dosage Forms:

Tablet

Tablet, Disintegrating

Solution

Therapeutic Class: Antipsychotic

Uses For Abilify Discmelt

Aripiprazole is used to treat nervous, emotional, and mental conditions (e.g., schizophrenia). It may be used alone or together with other medicines (e.g., lithium or valproate) for the acute or maintenance treatment of bipolar I disorder (manic-depressive illness). Additionally, it may be used together with other medicines for the treatment of major depressive disorder (MDD) in adults. It is also used to treat irritability in children 6 to 17 years of age with autistic disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.

This medicine is available only with your doctor's prescription.

Before Using Abilify Discmelt

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children with schizophrenia younger than 13 years of age and in children with bipolar disorder younger than 10 years of age. Safety and efficacy have not been established in these age groups.

Aripiprazole is not approved for use in children or teenagers with major depression.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children with autistic disorder 6 to 17 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Metoclopramide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Hydromorphone

Milnacipran

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine

Clarithromycin

Ketoconazole

Quinidine

Interactions with Food/Tobacco/Alcohol

Proper Use of aripiprazole

This section provides information on the proper use of a number of products that contain aripiprazole. It may not be specific to Abilify Discmelt. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Swallow the tablets whole. Do not break, crush, or chew them.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor's instructions.

Dosing

For bipolar mania:
- For oral dosage forms (tablets and orally disintegrating tablets):
  - Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
  - Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
  - Children younger than 10 years of age—Use and dose must be determined by your doctor.

For depression:
- For oral dosage forms (tablets, orally disintegrating tablets, and solution):
  - Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
  - Children—Use and dose must be determined by your doctor.

For irritability in children with autistic disorder:
- For oral dosage forms (tablets, orally disintegrating tablets, and solution):
  - Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
  - Children younger than 6 years of age—Use and dose must be determined by your doctor.

For schizophrenia:
- For oral dosage forms (tablets and orally disintegrating tablets):
  - Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
  - Teenagers 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
  - Children younger than 13 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Opened bottles of the oral liquid can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

Precautions While Using Abilify Discmelt

It is very important that your doctor check the progress of you or your child at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; medicines for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you or your child are taking this medicine.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.

Stop taking this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may increase the amount of sugar in your blood. Also, the oral liquid form contains sugar. Check with your doctor right away if you or your child have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.

Do not change the dose or stop taking this medicine without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Abilify Discmelt Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficulty with speaking

drooling

loss of balance control

muscle trembling, jerking, or stiffness

restlessness

shuffling walk

stiffness of the limbs

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

Less common

Blurred vision

dizziness

headache

inability to move the eyes

increased blinking or spasms of the eyelid

nervousness

pounding in the ears

slow or fast heartbeat

sticking out the tongue

trouble with breathing or swallowing

unusual facial expressions

Rare

Convulsions

fast heartbeat

high fever

high or low blood pressure

increased sweating

lip smacking or puckering

loss of bladder control

muscle spasm or jerking of all extremities

puffing of the cheeks

rapid or worm-like movements of the tongue

severe muscle stiffness

sudden loss of consciousness

tiredness

uncontrolled chewing movements

uncontrolled movements of the arms and legs

unusually pale skin

Incidence not known

Hives or welts

itching skin

itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

redness of the skin

shortness of breath

skin rash

tightness in the chest

unusual tiredness or weakness

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bigger, dilated, or enlarged pupils (black part of the eye)

diarrhea

fast, pounding, or irregular heartbeat or pulse

increased sensitivity of the eyes to light

lack or loss of strength

nausea

sleepiness or unusual drowsiness

vomiting

More common

Acid or sour stomach

anxiety

belching

blurred vision

difficulty having a bowel movement (stool)

dry mouth

fear

fever

headache

heartburn

hyperventilation

inability to sit still

indigestion

irritability

lightheadedness

need to keep moving

nervousness

rash

runny nose

shaking

sleeplessness

sore throat

stomach discomfort, upset, or pain

trouble sleeping

unable to sleep

weight gain

Less common

Accidental injury

bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain

congestion

coughing

difficulty with moving

dryness or soreness of throat

hoarseness

increased appetite

increased salivation

joint pain

muscle aching or cramping

muscle pains or stiffness

rapid weight gain

sneezing

stuffy nose

swollen joints

tender, swollen glands in the neck

tingling of the hands or feet

tremor

unusual weight gain or loss

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Abilifymelt side effects (in more detail)

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Agitated State
Autism
Bipolar Disorder
Borderline Personality Disorder
Depression
Obsessive Compulsive Disorder
Post Traumatic Stress Disorder
Schizoaffective Disorder
Schizophrenia
Tourette's Syndrome

Asacol

Generic Name: mesalamine (oral) (me SAL a meen)

Brand Names: Apriso, Asacol, Asacol HD, Lialda, Pentasa

What is mesalamine oral?

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about mesalamine oral?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others). Before you take mesalamine, tell your doctor if you have kidney or liver disease, a stomach condition called pyloric stenosis, a heart condition such as congestive heart failure, or a history of allergy to sulfasalazine (Azulfidine). Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole. It is specially formulated to release the medicine after it has passed through your stomach into your intestines.

Call your doctor if you find undissolved tablets in your stool.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

What should I discuss with my healthcare provider before taking mesalamine oral?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

To make sure you can safely take mesalamine, tell your doctor if you have any of these other conditions:

a stomach condition called pyloric stenosis;

a history of allergy to sulfasalazine (Azulfidine);

a heart condition such as congestive heart failure;

kidney disease; or

liver disease.

FDA pregnancy category C. It is not known whether mesalamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Mesalamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take mesalamine oral?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take mesalamine with a full glass of water.

Mesalamine can usually be taken with or without food. Follow your doctor's instructions.

Mesalamine extended-release capsules (Lialda) should be taken with a meal. Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole.

The extended-release capsule is specially formulated to release the medicine after it has passed through your stomach into your intestines. Breaking the pill may cause the drug to be released too early in the digestive tract.

The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.

Call your doctor if you find undissolved tablets in your stool.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include ringing in your ears, dizziness, headache, confusion, drowsiness, sweating, shortness of breath, vomiting, and diarrhea.

What should I avoid while taking mesalamine oral?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Mesalamine oral side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking mesalamine and call your doctor at once if you have a serious side effect such as:

severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

mild nausea, vomiting, stomach cramps, diarrhea, gas;

fever, sore throat, or other flu symptoms;

constipation;

headache or dizziness;

tired feeling; or

skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect mesalamine oral?

Tell your doctor about all other medicines you use, especially:

azathioprine (Imuran) or mercaptopurine (Purinethol);

pentamidine (Nebupent, Pentam);

tacrolimus (Prograf);

amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);

antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);

antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid); or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), diclofenac (Voltaren), etodolac (Lodine), indomethacin, nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with mesalamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Asacol resources

Asacol Side Effects (in more detail)
Asacol Use in Pregnancy & Breastfeeding
Drug Images
Asacol Drug Interactions
Asacol Support Group
28 Reviews for Asacol - Add your own review/rating

Asacol Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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Asacol Prescribing Information (FDA)

Asacol Consumer Overview

Mesalamine Monograph (AHFS DI)

Mesalamine Prescribing Information (FDA)

Mesalamine Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Apriso Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Apriso Prescribing Information (FDA)

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Canasa Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

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Lialda Prescribing Information (FDA)

Pentasa Prescribing Information (FDA)

Pentasa Consumer Overview

Rowasa Prescribing Information (FDA)

Rowasa Enema MedFacts Consumer Leaflet (Wolters Kluwer)

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sfRowasa Prescribing Information (FDA)

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Crohn's Disease
Crohn's Disease, Maintenance
Inflammatory Bowel Disease
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Ulcerative Colitis
Ulcerative Colitis, Active
Ulcerative Colitis, Maintenance
Ulcerative Proctitis

Where can I get more information?

Your pharmacist can provide more information about mesalamine.

See also: Asacol side effects (in more detail)