Promene Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Promethazine HCl

Indications/Uses

Symptomatic treatment for upper resp tract & skin allergic conditions eg, allergic rhinitis, urticaria & anaphylactic reactions. Adjunct in pre-op sedation in surgery & obstet. Antiemetic. Short-term sedation & insomnia treatment in adult; paed sedative.

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Dosage/Direction for Use

Antihistamine Adult including elderly & childn >10 yr 25 single dose, may be increased to max: 25 mg bd as required, 5-10 yr 25 mg single dose. Max: 25 mg daily. Antiemetic Adult including elderly & childn >10 yr 25 mg taken the night before travel, may be repeated after 6-8 hr as required. Short-term sedation Adult including elderly & childn >10 yr 25 or 50 mg single nighttime dose, 5-10 yr 25 mg single nighttime dose.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Patients in coma or suffering from CNS depression. Avoid concomitant MAOI therapy for up to 14 days. Childn <2 yr.

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Special Precautions

Narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder-neck obstruction, CV disease, asthma, bronchitis, bronchiectasis. Concomitant use w/ alcohol or other CNS depressants. Avoid prolonged sun exposure. Treatment >7 days. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Hepatic impairment. Not to be used in pregnancy & not recommended 2 wk prior to delivery. Childn & adolescents w/ signs & symptoms suggestive of Reye's syndrome.

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Use In Pregnancy & Lactation

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Adverse Reactions

Drowsiness, sedation, somnolence, blurred vision, dizziness; confusion, disorientation, extrapyramidal symptoms; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria; hallucinations; increased or decreased BP, tachycardia, bradycardia, faintness; dermatitis, photosensitivity, urticaria; leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis; dry mouth, nausea, vomiting, jaundice; asthma, nasal stuffiness, resp depression, apnea; angioneurotic edema, NMS.

Storage

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Description

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Action

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MIMS Class

Antihistamines & Antiallergics / Antiemetics / Hypnotics & Sedatives

ATC Classification

R06AD02 - promethazine ; Belongs to the class of phenothiazine derivatives used as systemic antihistamines.

Regulatory Classification

Presentation/Packing

Form

Promene FC tab 25 mg

Packing/Price

30 × 10's

Promene

promethazine

Manufacturer:

Noripharma

Distributor:

Pahang Pharmacy