Otosil 25Tablet

Generic

Indications

• Long-acting antihistamine with anti-emetic and sedative/calming properties.
• Indicated for the symptomatic treatment of allergic respiratory and skin diseases.
• Anaphylactic responses to drugs or foreign proteins, as well as sensitization reactions.
• Sedation, allergic rhinitis, urticaria, and sleeplessness are all treated with this medication.
• As a pre-operative sedative in surgery and obstetrics.
• As a sedative for children

Pharmacology

Promethazine is a phenothiazine derivative that inhibits the brain's postsynaptic mesolimbic dopaminergic receptors. It has a significant -adrenergic blocking action and inhibits hypothalamus and hypophyseal hormone release. It competes with histamine for the H1-receptor; the antiemetic action may be due to the muscarinic blocking effect. It also lowers the amount of stimulation to the brainstem reticular system.

The gastrointestinal system absorbs promethazine effectively. Clinical effects are seen after 20 minutes of oral ingestion and typically last four to six hours, however they might last up to 12 hours. The liver metabolizes promethazine to a number of chemicals, the most common of which are promethazine sulfoxides and N-demethylpromethazine in the urine.

Dosage & Administration

Interaction

• Alcohol should be avoided during medication therapy since Promethazine Hydrochloride may enhance the activity of any anticholinergic substance, tricyclic antidepressant, sedative, or hypnotic.

• Phenergan may cause false-positive or false-negative findings in immunologic urine pregnancy tests.

• Phenergan should be stopped at least 72 hours before starting skin testing with allergen extracts since it inhibits the cutaneous histamine response, resulting in false-negative findings.

Contraindications

• Promethazine is not recommended for children under the age of two.
• Intolerance to promethazine or any of the excipients.
• Phenergan should not be administered in individuals who are in a coma or have CNS depression from any cause. It should not be administered to newborns or preterm babies.
• Phenergan should be avoided in individuals who have taken monoamine oxidase inhibitors in the last 14 days.

Side Effects

• Nervous System Disorders: Unknown Frequency: Neuroleptic Malignant Syndrome is a kind of neuroleptic malignant syndrome. The elderly are more vulnerable to Promethazine's anticholinergic effects and disorientation, as well as somnolence, dizziness, headaches, and extrapyramidal effects such as muscular spasm and tic-like movements of the head and face. Neuroleptic malignant syndrome (NMS) is a dangerous and sometimes fatal health condition that can occur. If you experience a high temperature, muscular cramps or stifness, dizziness, severe headache, rapid heartbeat, disorientation, agitation, hallucinations, or are sweating profusely, discontinue therapy and contact your doctor immediately.
• Promethazine is not recommended for children under the age of two.
• Intolerance to promethazine or any of the excipients.
• Phenergan should not be administered in individuals who are in a coma or have CNS depression from any cause. It should not be administered to newborns or preterm babies.
• Phenergan should be avoided in individuals who have taken monoamine oxidase inhibitors in the last 14 days.
• Eye Disorders- Frequency unknown: Blurred vision
• Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
• Renal and Urinary Disorders- Frequency unknown: Urinary retention
• Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
• Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
• Vascular disorders- Frequency unknown: Hypotension
• Hepatobiliary disorders- Frequency unknown: Jaundice

General Disorders and Administration Site Conditions- Frequency unknown: Tiredness

Pregnancy & Lactation

Although there is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have indicated no risk, it should not be taken in pregnancy unless the doctor believes it is absolutely necessary. The use of Phenergan in the two weeks preceding birth is not advised due to the possibility of irritability and excitation in the neonate. Promethazine has produced long-term neurological problems in infants when administered in large dosages during late pregnancy. Promethazine should only be taken during pregnancy if the potential benefits to the patient outweigh the potential risks to the fetus. Breastmilk contains promethazine.There is a possibility of neonatal irritability and excitation.

Precautions & Warnings

• The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
• Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
• Use with care in patients with severe coronary artery disease.
• Use with care in patients with narrow angle glaucoma.
• Use with care in patients with epilepsy.
• Use with care in patients with hepatic insufciency.
• Use with care in patients with renal insufciency.
• Caution should be exercised in patients with bladder neck obstruction.
• Caution should be exercised in patients with pyloro-duodenal obstruction.

Therapeutic Class

Storage Conditions

Keep out of direct sunlight. Do not use after the expiry date. Keep any medications out of children's reach. Only on the prescription of a qualified physician can it be dispensed.

Pharmaceutical Name