Hismanal (Astemizole (WITHDRAWN FROM US MARKET)) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Hismanal

Hay Fever »

What is hay fever? What are the symptoms and signs?

Hay fever is a misnomer. Hay is not a usual cause of this problem, and it does not cause fever. Early descriptions of sneezing, nasal congestion, and eye irritation while harvesting field hay promoted this popular term. Allergic rhinitis is the correct term used to describe this allergic reaction, and many different substances cause the allergic symptoms noted in hay fever. Rhinitis means "irritation of the nose" and is a derivative of rhino, meaning nose. Allergic rhinitis which occurs during a specific season is called "seasonal allergic rhinitis." When it occurs throughout the year, it is called "perennial allergic rhinitis." Rhinosinusitis is the medical term that refers to inflammation of the nasal lining as well as the lining tissues of the sinuses. This term is sometime used because the two conditions frequently occur together.

Symptoms of allergic rhinitis, or hay fever...

Read the Hay Fever article »

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Hismanal

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Please Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

SIDE EFFECTS

For information regarding cardiovascular adverse events (e.g., cardiac arrest, ventricular arrhythmias), please see CONTRAINDICATIONS and WARNINGS. In some cases, recognition of severe arrhythmias has been preceded by episodes of syncope. Similarly, rare cases of hypotension, palpitations, and dizziness have also been reported with Astemizole use, which may reflect undetected ventricular arrhythmia.

In studies the usual maintenance dose of Astemizole was 10 mg once daily.

TABLE 1 - Astemizole, Adverse Reactions Percent of Patients Reporting Controlled Studies*

Adverse Event	Astemizole	Placebo	Classical**
	(N = 1630)	(N = 1109)	(N = 304)
	%	%	%
Central Nervous System
Drowsiness	7.1	6.4	22.0
Headache	6.7	9.2	3.3
Fatigue	4.2	1.6	11.8
Appetite increase	3.9	1.4	0.0
Weight increase	3.6	0.7	1.0
Nervousness	2.1	1.2	0.3
Dizzy	2.0	1.8	1.0
Gastrointestinal System
Nausea	2.5	2.9	1.3
Diarrhea	1.8	2.0	0.7
Abdominal pain	1.4	1.2	0.7
Eye, Ear, Nose, and Throat
Mouth dry	5.2	3.8	7.9
Pharyngitis	1.7	2.3	0.3
Conjunctivitis	1.2	1.2	0.7
Other
Arthralgia	1.2	1.6	0.0
* Duration of treatment in Controlled Studies ranged from 7 to 182 Days
** Classical Drugs: Clemastine (N = 137); Chlorpheniramine (N = 100); Pheniramine Maleate (N = 47); d-Chlorpheniramine (N = 20)

Adverse reaction information has been obtained from more than 7500 patients in all clinical trials. Weight gain has been reported in 3.6% of astemizole treated patients involved in controlled studies, with an average treatment duration of 53 days. In 46 of the 59 patients for whom actual weight gain data was available, the average weight gain was 3.2 kg.

Less frequently occurring adverse experiences reported in clinical trials or spontaneously from marketing experience with Astemizole include: angioedema, asymptomatic liver enzyme elevations, bronchospasm, depression, edema, epistaxis, myalgia, palpitation, paresthesia, photosensitivity, pruritus, and rash.

Marketing experiences include isolated cases of convulsions. A causal relationship with Astemizole has not been established.

DRUG INTERACTIONS

See CONTRAINDICATIONS and WARNINGS for discussion of information regarding potential drug interactions.

Ketoconazole/Itraconazole: Concomitant administration of ketoconazole tablets or itraconazole with astemizole is contraindicated. (See CONTRAINDICATIONS and WARNINGS.)

Due to the chemical similarity of fluconazole, metronidazole, and miconazole IV to ketoconazole, concomitant use of these products is not recommended.

Macrolides (Including Erythromycin): Concomitant administration of erythromycin with astemizole is contraindicated. (See CONTRAINDICATIONS and WARNINGS.) Concomitant administration of astemizole with other macrolide antibiotics, including troleandomycin, azithromycin, and clarithromycin, is not recommended.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.