Otosil may cause excessive drowsiness with alcohol.
CONSULT YOUR DOCTOR
Otosil may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
SAFE IF PRESCRIBED
Otosil is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby. For prolonged use and repeated doses of Otosil, observe the baby for excessive sleepiness.
Otosil may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
SAFE IF PRESCRIBED
Otosil is probably safe to use in patients with kidney disease. Limited data available suggests that dose adjustment of Otosil may not be needed in these patients. Please consult your doctor. However, caution is advised in patients with severe kidney disease as it may cause excessive sleepiness in them.
Otosil should be used with caution in patients with liver disease. Dose adjustment of Otosil may be needed. Please consult your doctor.
Otosil used in the treatment of various allergic conditions like runny nose, sneezing, congestion, itching and watery eyes. It also treats nausea, vomiting and insomnia (difficulty in sleeping) in adults and used as a sedative (sleep causing) in children (for 5 years and above). Otosil should be taken with or without food, but take it at the same time every day to get the most benefit. The dose and how often you take it depends on what you are taking it for. Your doctor will decide how much you need to improve your symptoms. You should take this medicine for as long as it is prescribed for you. In case, you have missed any doses than it is better to take the next dose as soon as you remember it. However, you should never take a double dose. you must inform your doctor if symptoms does not get improve within 7 days of treatment. The most common side effects of this medicine include dry mouth, blur vision, headache, and feeling dizzy. If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them. It makes skin more sensitive towards sunlight. use sunscreen or wear protective clothing before going out. Before taking this medicine, let your doctor know if you have glaucoma or have asthma issues or have high blood pressure. Inform your doctor if you are pregnant, or breastfeeding. Your doctor should also know about all other medicines you are taking as many of these may make this medicine less effective or change the way it works. Generally, it is advised to avoid alcohol while on treatment.
Uses of Otosil
Side effects of Otosil
- Dryness in mouth
- Blurred vision
How to use Otosil
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Otosil may be taken with or without food, but it is better to take it at a fixed time.
How Otosil works
Otosil is an antiallergic medication. When your body is exposed to an allergen (pollen, animal dander, house dust etc.), it produces a chemical called histamine. This causes watery eyes, runny or blocked nose, sneezing, skin rashes, itching etc. Otosil works by blocking the action of histamine, thereby relieving these symptoms. It also works directly on several areas of the brain to prevent nausea/vomiting and help you feel more relaxed.
What if you forget to take Otosil?
If you miss a dose of Otosil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
- Otosil helps treat nausea and vomiting.
- It may also be used for the short-term treatment of sleeping difficulties (insomnia) in adults and as a sedative in children.
- Use caution while driving or doing anything that requires concentration as Otosil can cause dizziness and sleepiness.
- Do not drink alcohol while taking this medication as it may cause increased sleepiness.
- It may make your skin more sensitive to sunlight. Avoid exposing your skin to strong sunlight, use a sunscreen lotion or make sure your skin is protected with clothing.
- Do not take it for longer than 7 days. If your symptoms worsen or do not improve after 7 days, talk to your doctor.
- Stop taking it at least three days before taking an allergy test as it can affect the test results.
Allergic conditions, Nausea and vomiting, Motion sickness, Insomnia
May be taken with or without food.
Oral Allergic conditions Adult: As promethazine HCl: 25 mg at night, increase to 25 mg bid if necessary. Alternatively, 10-20 mg 2-3 times daily. Prophylaxis of motion sickness Adult: As promethazine HCl: 20 mg or 25 mg the night before travelling, followed by a similar dose the following morning if necessary. As promethazine teoclate: 25 mg given on the night or 1-2 hr before travelling. Short-term management of insomnia Adult: As promethazine HCl: 20-50 mg at night. Parenteral Allergic conditions; Sedation Adult: As promethazine HCl: 25-50 mg, by deep IM, IV inj or IV infusion at a rate of not more than 25 mg/min. Max: 100 mg. Nausea and vomiting Adult: As promethazine HCl: 12.5-25 mg, repeated at intervals of not less than 4 hr. Max: 100 mg daily.
Oral Allergic conditions Child: As promethazine HCl: 2-5 yr 5-15 mg daily in 1 or 2 divided doses; >5-10 yr 10-25 mg daily in 1 or 2 divided doses. Prophylaxis of motion sickness Child: As promethazine HCl: 2-5 yr 5 mg; >5-10 yr 10 mg. Doses are given the night before the journey and repeated on the following morning (6-8 hr later) if necessary. Short-term management of insomnia Child: As promethazine HCl: 2-5 yr 15-20 mg; >5-10 yr 20-25 mg. Parenteral Allergic conditions; Sedation Child: As promethazine HCl: 5-10 yr 6.25-12.5 mg by deep IM.
Renal impairment: Dose reduction may be required.
Patients in coma or suffering from CNS depression of any cause. Childn <2 yr. SC and intra-arterial admin. Concurrent use w/ or w/in 14 days of MAOI use.
Mode of Action
Promethazine, a phenothiazine derivative, blocks postsynaptic dopaminergic receptors in the brain and has a strong alpha-adrenergic blocking effect. It competitively binds to H1-receptors.
Patient w/ asthma, bronchitis or bronchiectasis; severe coronary artery disease, narrow-angle glaucoma, epilepsy, bladder neck or pyloro-duodenal obstruction, Reye's syndrome, bone marrow depression, Hepatic and renal impairment. Pregnancy and lactation. Patient Counselling This drug may cause marked drowsiness, if affected, do not drive or operate machinery. Avoid prolonged exposure to sunlight. Monitoring Parameters Monitor mental status; signs and symptoms of tissue injury (IV inj). Lactation: Not known whether drug crosses into breast milk; discontinue drug, or do not nurse
Neuroleptic Malignant Syndrome (NMS); CV effects (e.g. bradycardia, tachycardia, transient HTN, hypotension; jaundice, blood dyscrasias, extrapyramidal effects; IV inj: Severe tissue injury (e.g. gangrene), pain and burning, paralysis, thrombophlebitis, severe spasm of distal vessels, necrosis. Sedation, Confusion, Disorientation, Blurred vision, Hallucinations, Dystonias, Catatonic states, Euphoria, Excitation, Impotence, Urinary retention Potentially Fatal: Resp depression and apnoea esp in childn.
Masks ototoxicity of aminoglycoside antibiotics. May enhance the sedative effects of CNS depressants like alcohol, hypnotics, barbiturates and opioids. Potentially Fatal: Ventricular arrhythmias when used with drugs that prolong QT interval. Increased risk of extrapyramydal effects w/ MAOIs.
The information provided herein is accurate, updated and complete as per the best practices of the Company. Please note that this information should not be treated as a replacement for physical medical consultation or advice. We do not guarantee the accuracy and the completeness of the information so provided. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company. We do not take any responsibility for the consequences arising out of the aforementioned information and strongly recommend you for a physical consultation in case of any queries or doubts.