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Indications & Uses
Promestin is indicated for:
Pharmacology
Promethazine, a phenothiazine derivative, blocks postsynaptic mesolimbic dopamine receptors in the brain. It has a strong α-adrenergic blocking effect and suppresses the release of hypothalamic and hypophyseal hormones. By competing with histamine for the H1-receptor, and through a muscarinic blocking effect that may account for its antiemetic action, it also reduces stimuli reaching the brainstem reticular system.
Taken orally, promethazine is well absorbed from the gastrointestinal tract. Its clinical effects appear within 20 minutes and generally last four to six hours, though they may persist for up to 12 hours. The liver metabolizes promethazine into a variety of compounds, with promethazine sulfoxide and N-demethylpromethazine sulfoxide as the main metabolites found in the urine.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Oral dose for adults: Start with one 25 mg tablet at night. This may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions, more frequent administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required. Elderly: No specific dosage recommendations. Children: They may be treated more conveniently with the elixir containing 5 mg per 5 ml. As an antihistamine in allergy, children aged 2 to 5 years may be given 5 to 15 mg, and children aged 5 to 10 years 10 to 25 mg. Where two doses are required in 24 hours, the lower dose stated should be given. As a sedative, children aged 2 to 5 years may be given 15 to 20 mg, and children aged 5 to 10 years 20 to 25 mg, given as a single night-time dose. Parenteral dose for adults: 25 to 50 mg by deep intramuscular injection or, in an emergency, by slow intravenous injection after diluting the 2.5% solution to 10 times its volume with water for injection. The maximum parenteral dose is 100 mg. Children aged 5 to 10 years: 6.25 to 12.5 mg by deep intramuscular injection.
Side Effects
Nervous system disorders (frequency unknown): The elderly are especially prone to the anticholinergic effects of Histaphen, and these can cause confusion. Other effects include drowsiness, dizziness, headaches, and extrapyramidal effects such as muscle spasms and tic-like movements of the head and face. A very serious and sometimes fatal condition called neuroleptic malignant syndrome (NMS) can also occur. Stop taking the medicine and call your doctor straight away if you develop a high fever, muscle cramps or stiffness, dizziness, a very bad headache, a fast heartbeat, confusion, agitation, hallucinations, or heavy sweating. Immune system disorders (frequency unknown): Allergic reactions have been reported, including urticaria, rash, itching, and anaphylaxis. Skin and subcutaneous tissue disorders (frequency unknown): Photosensitivity reactions. Metabolism and nutrition disorders (frequency unknown): Loss of appetite. Gastrointestinal disorders (frequency unknown): Discomfort in the upper stomach and dry mouth. Eye disorders (frequency unknown): Blurred vision. Blood and lymphatic system disorders (frequency unknown): Blood dyscrasias, including haemolytic anaemia and agranulocytosis. Renal and urinary disorders (frequency unknown): Difficulty passing urine (urinary retention). Psychiatric disorders (frequency unknown): Infants, newborns and premature babies are sensitive to the anticholinergic effects of promethazine. Other children may instead show paradoxical hyperexcitability, restlessness, nightmares, and disorientation. Cardiac disorders (frequency unknown): Palpitations and arrhythmias. Vascular disorders (frequency unknown): Low blood pressure (hypotension). Hepatobiliary disorders (frequency unknown): Jaundice. General disorders and administration site conditions (frequency unknown): Tiredness. Take Histaphen only as recommended, and never go above the recommended dose. There have been case reports of promethazine abuse. Do not take it for longer than 10 days.
Cautions & Contraindications
Warnings & Precautions
Promethazine should not be used in children and adolescents who show signs and symptoms suggestive of Reye's syndrome. Histaphen may thicken or dry lung secretions and make it harder to cough them up, so it should be used with caution in patients with asthma, bronchitis or bronchiectasis. Care is also needed in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy, hepatic insufficiency or renal insufficiency. Caution should likewise be exercised in patients with bladder neck obstruction or pyloro-duodenal obstruction.
Contraindications
Promethazine must not be used in children under two years of age, and it must not be given to neonates or premature infants. It is also contraindicated in anyone with hypersensitivity to promethazine or to any of the excipients. Phenergan should not be used in patients who are in a coma or who have CNS depression of any cause. Phenergan should be avoided in patients who have taken monoamine oxidase inhibitors within the previous 14 days.
Pregnancy & Breastfeeding
Pregnancy & Breastfeeding: Studies in humans and animals have not shown promethazine to be harmful during pregnancy, but it should still be avoided unless your physician feels it is clearly needed. Phenergan is not recommended in the two weeks before delivery, as it may cause irritability and excitability in the newborn. When taken in high doses late in pregnancy, promethazine has been linked to prolonged neurological disturbances in infants. It should therefore be used during pregnancy only after weighing the potential benefits to the mother against the possible risks to the baby. Promethazine passes into breastmilk and may cause irritability and excitability in a nursing infant.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
The signs of a severe overdose of Promethazine Hydrochloride vary from one person to another. In children, they usually appear as some mix of excitation, ataxia, incoordination, athetosis and hallucinations. Adults, on the other hand, may become drowsy and slip into coma. Convulsions can happen in both adults and children, and coma or excitement may come before them. Tachycardia may develop. Cardiorespiratory depression is uncommon.
If the patient is seen soon enough after taking the tablets, vomiting can be induced with ipecacuanha, even though promethazine itself has an antiemetic effect. Gastric lavage may be used instead. Beyond this, treatment is supportive, with attention to keeping breathing and circulation adequate. Convulsions should be treated with diazepam or another suitable anticonvulsant.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Promethazine Hydrochloride away from light. Don't use it after the expiry date. Keep all medicines out of the reach of children. Promethazine Hydrochloride should be dispensed only on the prescription of a registered physician.
Common questions about Promestin 5 mg/5 ml
What is Promestin 5 mg/5 ml Oral Solution?
Promestin 5 mg/5 ml Oral Solution is a medicine that contains Promethazine Hydrochloride. It is made by Pharmadesh Laboratories Ltd. It belongs to the Anti-emetic drugs group of medicines.
What is Promestin used for?
Promestin is used for: Allergic Rhinitis, Urticaria, Insomnia, Allergy.
What are the side effects of Promestin?
Nervous system disorders (frequency unknown): The elderly are especially prone to the anticholinergic effects of Histaphen, and these can cause confusion. Other effects include drowsiness, dizziness, headaches, and extrapyramidal effects such as muscle spasms and tic-like movements of the head and face.
Can I take Promestin during pregnancy or while breastfeeding?
Pregnancy & Breastfeeding: Studies in humans and animals have not shown promethazine to be harmful during pregnancy, but it should still be avoided unless your physician feels it is clearly needed. Phenergan is not recommended in the two weeks before delivery, as it may cause irritability and excitability in the newborn. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Promestin?
The signs of a severe overdose of Promethazine Hydrochloride vary from one person to another. In children, they usually appear as some mix of excitation, ataxia, incoordination, athetosis and hallucinations. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Promestin?
Keep Promethazine Hydrochloride away from light. Don't use it after the expiry date.
Do I need a prescription for Promestin?
Promestin is a prescription (Rx) medicine. Take it as your doctor advises.