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AA Pharma Hydroxyzine

AA Pharma Hydroxyzine

hydroxyzine

Manufacturer:

AA Pharma

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Hydroxyzine HCl.
Description
Each soft gelatin capsule contains: hydroxyzine HCl 10mg (orange), 25mg (green). Energy: 0.005 kJ (0.001 kcal).
Excipients/Inactive Ingredients: Gluten-, sodium- and tartrazine-free.
Indications/Uses
Oral. The management of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. Also used in the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses. Useful in the control of nausea and vomiting, excluding nausea and vomiting of pregnancy (see Contraindications).
Dosage/Direction for Use
Dosage: Oral: Dosage is dependent upon the intensity of the emotional disturbance, rather than upon the weight of the patient.
Adults: 25 to 100mg 3 or 4 times a day.
Children: Under 6 years, 30 to 50mg daily in divided doses; over 6 years, 50 to 100mg daily in divided doses.
Overdosage
Treatment: Gastric lavage, when necessary.
Contraindications
In patients with known hypersensitivity to the drug.
Warnings
Lactation: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
Special Precautions
The potentiating effect of hydroxyzine must be considered when the drug is used in conjunction with CNS depressants such as narcotics, non-narcotic analgesics, hypnotics, sedatives, psychotherapeutic agents, barbiturates or alcohol. Therefore, when CNS depressants are administered concomitantly with hydroxyzine, their dosage should be reduced.
Administer hydroxyzine cautiously to epileptic patients.
Occupational hazards: Since drowsiness may occur with use of this drug, patients should be cautioned against driving a car or operating dangerous machinery while taking hydroxyzine.
Use In Pregnancy & Lactation
Pregnancy: Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities at doses substantially above the human therapeutic range. Clinical data in humans are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.
Lactation: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
Adverse Reactions
Side effects reported with the administration of hydroxyzine are usually mild and transitory in nature.
Anticholinergic: Dry mouth may be encountered at higher dosages.
CNS: drowsiness.
Involuntary motor activity, including rare instances of tremor and convulsions, has been reported usually with doses considerably higher than those recommended.
Storage
Store in a cool place. Protect from light.
MIMS Class
Anxiolytics
ATC Classification
N05BB01 - hydroxyzine ; Belongs to the class of diphenylmethane derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Presentation/Packing
Form
AA Pharma Hydroxyzine cap 10 mg
Packing/Price
100's
Form
AA Pharma Hydroxyzine cap 25 mg
Packing/Price
100's
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