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Hismanal

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Hismanal

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

Side Effects
Interactions

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)
% % %
Drowsiness
7.1 6.4 22.0
Headache
6.7 9.2 3.3
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
2.5 2.9 1.3
1.8 2.0 0.7
1.4 1.2 0.7
5.2 3.8 7.9
1.7 2.3 0.3
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.

Read the Hismanal (astemizole (withdrawn from us market)) Side Effects Center for a complete guide to possible side effects

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.

Side Effects
Interactions
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