An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Oral
Adjunct in parkinsonism
Adult: Arteriosclerotic and idiopathic parkinsonism: Initially, 0.5-1 mg at bedtime, some may initiate 4-6 mg daily. Postencephalitic parkinsonism: Initially, 2 mg daily as a single or in divided doses; may initiate 0.5 mg at bedtime in highly-sensitive patient. Gradually increase dose by 0.5 mg every 5-6 days if necessary.
Maintenance: May be given as a single dose at bedtime or in 2-4 divided doses. Max: 6 mg daily.
Oral
Drug-induced extrapyramidal symptoms
Adult: 1-4 mg once daily or bid. Stop therapy after 1-2 wk to assess whether it is still needed.
Parenteral
Adjunct in parkinsonism
Adult: Arteriosclerotic and idiopathic parkinsonism: Initially, 0.5-1 mg at bedtime by IM or IV inj, some may initiate 4-6 mg daily. Postencephalitic parkinsonism: Initially, 2 mg daily as a single or in divided doses by IM or IV inj; may initiate 0.5 mg at bedtime in highly-sensitive patient. Gradually increase dose by 0.5 mg every 5-6 days if necessary.
Maintenance: May be given as a single dose at bedtime or in 2-4 divided doses. Max: 6 mg daily.
Parenteral
Drug-induced extrapyramidal symptoms
Adult: 1-4 mg once daily or bid by IM or IV inj. Stop therapy after 1-2 wk to assess whether it is still needed.
Parenteral
Acute dystonia
Adult: 1-2 mg by IM or IV inj. May be followed by 1-2 mg once daily to bid orally for up to 7-28 days to prevent recurrence.
Benztropine Pendopharm description
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A centrally active muscarinic antagonist that has been used in the symptomatic treatment of parkinson disease. Benztropine Pendopharm also inhibits the uptake of dopamine.
Benztropine Pendopharm dosage
Benztropine Pendopharm tablets should be used when patients are able to take oral medication.
The injection is especially useful for psychotic patients with acute dystonic reactions or other reactions that make oral medication difficult or impossible. It is recommended also when a more rapid response is desired than can be obtained with tablets.
Because of cumulative action, therapy should be initiated with a low dose which is increased gradually at five or six-day intervals to the smallest amount necessary for optimal relief. Increases should be made in increments of 0.5 mg, to a maximum of 6 mg, or until optimal results are obtained without excessive adverse reactions.
Postencephalitic and Idiopathic Parkinsonism -
The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg orally or parenterally.
As with any agent used in parkinsonism, dosage must be individualized according to age and weight, and the type of parkinsonism being treated. Generally, older patients, and thin patients cannot tolerate large doses. Most patients with postencephalitic parkinsonism need fairly large doses and tolerate them well. Patients with a poor mental outlook are usually poor candidates for therapy.
In idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 to 1 mg at bedtime. In some patients, this will be adequate; in others 4 to 6 mg a day may be required.
In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses. In highly sensitive patients, therapy may be initiated with 0.5 mg at bedtime, and increased as necessary.
Some patients experience greatest relief by taking the entire dose at bedtime; others react more favorably to divided doses, two to four times a day. Frequently, one dose a day is sufficient, and divided doses may be unnecessary or undesirable.
The long duration of action of this drug makes it particularly suitable for bedtime medication when its effects may last throughout the night, enabling patients to turn in bed during the night more easily, and to rise in the morning.
When Benztropine Pendopharm is started, do not terminate therapy with other antiparkinsonian agents abruptly. If the other agents are to be reduced or discontinued, it must be done gradually. Many patients obtain greatest relief with combination therapy.
Benztropine Pendopharm may be used concomitantly with Carbidopa-Levodopa, or with levodopa, in which case periodic dosage adjustment may be required in order to maintain optimum response.
Drug-Induced Extrapyramidal Disorders -
In treating extrapyramidal disorders due to neuroleptic drugs (e.g., phenothiazines), the recommended dosage is 1 to 4 mg once or twice a day orally or parenterally. Dosage must be individualized according to the need of the patient. Some patients require more than recommended; others do not need as much.
When extrapyramidal disorders develop soon after initiation of treatment with neuroleptic drugs (e.g., phenothiazines), they are likely to be transient. One to 2 mg of Benztropine Pendopharm tablets two or three times a day usually provides relief within one or two days. After one or two weeks the drug should be withdrawn to determine the continued need for it. If such disorders recur, Benztropine Pendopharm can be reinstituted.
Certain drug-induced extrapyramidal disorders that develop slowly may not respond to Benztropine Pendopharm.
How supplied
Benztropine Pendopharm Tablets, USP are available as follows:
0.5 mg white, round, bisected, compressed tablets, debossed "Par 164", in bottles of 100 (NDC 49884-164-01), 500 (NDC 49884-164-05), and 1000 (NDC 49884-164-10) tablets.
1 mg white, pumpkin seed shaped, bisected, compressed tablets, debossed "Par 165", in bottles of 100 (NDC 49884-165-01), 500 (NDC 49884-165-05), and 1000 (NDC 49884-165-10) tablets.
2 mg white, round, bisected, compressed tablets, debossed "Par 166", in bottles of 100 (NDC 49884-166-01), 500 (NDC 49884-166-05), and 1000 (NDC 49884-166-10) tablets.
Dispense in a well-closed container as defined in the USP.
Store below 30°C (86°F).
Manufactured by: PAR PHARMACEUTICAL, INC., Spring Valley, NY 10977
Revised: 09/05
FDA rev date: 5/22/2001
Benztropine Pendopharm interactions
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Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants.
Pediatric Use
Because of the atropine-like side effects, Benztropine Pendopharm should be used with caution in pediatric patients over three years of age.
Benztropine Pendopharm side effects
The adverse reactions below, most of which are antichlolinergic in nature, have been reported and within each category are listed in order of decreasing severity.
If dry mouth is so severe that there is difficulty in swallowing or speaking, or loss of appetite and weight, reduce dosage, or discontinue the drug temporarily.
Slight reduction in dosage may control nausea and still give sufficient relief of symptoms. Vomiting may be controlled by temporary discontinuation, followed by resumption at a lower dosage.
Nervous System
Toxic psychosis, including confusion, disorientation, memory impairment, visual hallucinations; exacerbation of pre-existing psychotic symptoms; nervousness; depression; listlessness; numbness of fingers.
Special Senses
Blurred vision, dilated pupils.
Urogenital
Urinary retention, dysuria.
Metabolic/Immune or Skin
Occasionally, an allergic reaction, e.g., skin rash, develops. If this can not be controlled by dosage reduction, the medication should be discontinued.
Other
Heat stroke, hyperthermia, fever.
Benztropine Pendopharm contraindications
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Hypersensitivity to Benztropine Pendopharm tablets.
Because of its atropine-like side effects, this drug is contraindi-cated in pediatric patients under three years of age, and should be used with caution in older pediatric patients.
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