Aptofen Tablet is manufactured by Apollo Pharmaceutical Laboratories Ltd. Aptofen Tablet contains 1 mg Ketotifen Fumarate (Oral). It is Cromoglycate & related drugs class drug.
Ketotifen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Ketotifen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Ketotifen also stabilizes mast cells, decreases chemotaxis, activation of degranulation of eosinophils. Also, it stabilizes mast cells & basophils and inhibits PAF (platelet activating factor) and is effective in preventing asthmatic attacks.
Ketotifen is used for the prophylactic treatment of bronchial asthma, symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
Ketotifen has antiallergic properties and has been used similarly, to Sodium Chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing asthmatic attack. Ketotifen exerts sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its antianaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as administered by inhalation as a selective mast cell stabiliser. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.
|Generic:||Ketotifen Fumarate (Oral)|
|Therapeutic Class:||Cromoglycate & related drugs|
|Manufacturer:||Apollo Pharmaceutical Laboratories Ltd|
|Last Updated:||November 20, 2020 at 6:15 pm|
Table Of contents
Aptofen contains Ketotifen Fumarate (Oral) 1 mg. Aptofen Dosage:
Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.
Children above 2 years: 1 mg twice daily with food. Patient’s known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment, but usually disappear spontaneously after a few days.
It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If intercurrent infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patient should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotic, antihistamines and alcohol.
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetics and it has been suggested that this combination should therefore be avoided. Since Ketotifen has the properties of the antihistamines, it may potentiate the effects of other CNS depressant drugs such as alcohol, antihistamines, hypnotics and sedatives.
Pregnancy Lactation use
Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.
A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided.
Symptoms: Drowsiness, confusion, dyspnoea, bradycardia or tachycardia, disorientation, convulsions, severe hypotension, reversible coma.
Management: Supportive and symptomatic.
Interaction with other Medicine
Store at 25° C.
What is Aptofen?
Aptofen is a type of asthma medication which, when taken every day and used along with other antiasthma medications, may reduce the frequency, severity, and duration of asthma symptoms or attacks in children. It may also lead to a reduction in daily requirements of other antiasthma medications. Aptofen is not effective for the prevention or treatment of acute asthma attacks. Aptofen works by inhibiting certain substances in the body that are known to cause inflammation and symptoms of asthma.
What does Aptofen used for?
Aptofen is used to minimize the frequency and severity of asthma attacks. This medication may allow for a reduction in the use of other asthma medications. Aptofen is not effective in treating an active asthma attack (acute attack).
How quickly does Aptofen work?
It may take 2 to 3 months for this medication to have an effect. Your doctor may also adjust the dosage of your other asthma medications while you are taking Aptofen.
Is Aptofen a first generation antihistamine?
Aptofen, a first-generation antihistamine, is the antihistamine drug with the biggest category of evidence (systematic review with meta-analysis) for the control of asthma and wheezing in children, mainly in atopic children.
Does Aptofen make me sleepy?
Aptofen may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Why does Aptofen cause weight gain?
Leptin acts on receptors in the hypothalamus of the brain, where it inhibits appetite. Aptofen by inhibitory effect on production of TNF-α can reduce leptin level and thereby decreased the inhibition of leptin on appetite and finally result in weight gain.
Does Aptofen help with anxiety?
Aptofen can reduce behavioural suppression in rodent models of anxiety and attenuate the behavioural consequences of withdrawal from treatment with drugs of abuse.
Is Aptofen sedative?
Aptofen is described as a prophylactic antiasthma compound. Its predominant effect is histamine H1-receptor antagonism, which accounts for its sedative effect. Aptofen has little effect in clinical asthma—in acute challenge, on airway hyperresponsiveness, or on clinical symptoms.
How to take Aptofen?
Take Aptofen by mouth; generally twice daily. Do not crush or chew the tablets. Aptofen must be taken regularly to be effective. Do not skip any doses.
Is Aptofen safe?
The FDA has determined that Aptofen (ketotifen fumarate) is safe for OTC use based on the long-term use of the drug, as well as the controlled clinical studies that supported the original prescription-strength formula.
Is Aptofen safe for children?
Aptofen should be given for a year or longer to older children (older than 30 months) who have shown an initial good response to the drug.
What is the half life of Aptofen?
Clearance of the drug from plasma is biphasic, with a half-life of distribution of 3 hours and a half-life of elimination of 22 hours in adults. However, the onset of action of Aptofen is slow, and it may take 4 to 6 weeks to achieve full prophylactic value under certain conditions.
What are the side effects of Aptofen?
Side effects of Aptofen are Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment, but usually disappear spontaneously after a few days.
Is Aptofen safe during pregnancy?
Aptofen is considered a FDA pregnancy category C agent. Animal data reveal no harmful effects of ketotifen during pregnancy. No adequate and well-controlled studies of Aptofen in pregnant women have been performed.