Shiba Pharma | Rivopam Drops & Tabs

Section :

CNS Products

Rivopam Drops & Tabs

COMPOSITION :

Each tablet contains : Clonazepam 2 mg.

Each Iml of oral drops contains =: Clonazepam 2.5 mg.

DESCRIPTION :

Rivopam (clonazepam ) belongs to a group of medicines called ‘benzodiazepines’. Rivopam enhances the activity

of the inhibitory action neurotransmitter Gamma-Aminobutyric acid (GABA) , that is the major inhibitory

neurotransmitter in the central nervous system . It acts by binding to the benzodiazepine site of the GABA

receptors and decreasing any excessive electrical nerve activity in the CNS that might be contributing to seizures ,

this inhibition lead to anticonvulsant, skeletal muscle relaxant, and anxiolytic effects.

INDICATIONS :

Rivopam is used to treat :

- Epilepsy in infant, children and adult.

- As alone or an adjunct in treatment of lennox-gastaut syndrome (petit mal variant), akinetic, myoclonic seizures.

It is may be useful in patients with absence seizures (petit mal) who have failed to respond to succinimides drugs.

- Panic disorders with or without agoraphobia.

DOSAGE & ADMINISTRATION :

It is used with the lowest dose and period as possible. The dosage of Rivopam must be individually adjusted

according to the patient’s clinical response and tolerance. In order to minimise initial adverse reactions, it should

be started with low doses and increase the daily dose progressively until a maintenance dose suited to the

individual patient has been reached.

- Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Seizure Disorders:

Infants up to 12 months: the initial dose is 0.25 mg per day or less, and the dose is gradually increased to 0.5 to 1.0 mg per day.

Children from 1 to 5 years: the initial dose is 0.25 mg per day or less, and the dose is gradually increased to 1 to 3 mg per day.

Children from 5 to 12 years: the initial dose is 0.5 mg per day or less, and the dose is gradually increased to 3 to 6 mg per day.

Adults and children over 12 years of age: the initial dose is 1 mg per day or less, and the dose is gradually increased to 4 to 8 mg per day.

Elderly people 65+: The initial dose is 0.5 mg per day or less, and the dose is gradually increased to 4 to 8 mg per day . max does 20 mg.

Panic disorders:

- Adult : The initial dose 0.25 mg twice daily, An increase to the target dose for most patients of 1 mg/day may be

made after 3 days. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and

were associated with more adverse effects. some individual patients may benefit from doses of up to a maximum

dose of 4 mg/day.

- Children: There is no clinical trial experience in panic disorder patients under 18 years of age.

- Hepatic Impairment :Patients with severe hepatic impairment should not be treated with clonazepam. Patients

with mild to moderate hepatic impairment should be given the lowest possible dose.

RESTRICTIONS ON USE :

Contraindications

-Hypersensitivity to Clonazepam or to Other ‘benzodiazepine’ medicines

- patients with severe respiratory insufficiency or severe hepatic impairment as benzodiazepines may precipitate

hepatic encephalopathy

- Dependance on medication

- Patients with myasthenia gravis, acute narrow angle glaucoma

Precautions

The caution should be taken in patient with:

- severe liver damage, porphyria (abnormal haemoglobin metabolism).

- Spinal or cerebellar ataxia (where you may become shaky and unsteady, have slurred speech or rapid eye

movement )

- Acute intoxication due to alcohol, sleep apnea

- Careful dosage adjustment is required in elderly, patients with pre-existing disease of respiratory system, liver or

kidney

* If the dose of Rivopam has to be reduced or stopped, this must be done gradually to avoid withdrawal symptoms.

- Patients treated with any Antiepileptic drugs for any indication should be monitored for the emergence or

worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

- When taking this medicine there is a risk of dependence which increases with the dose and duration of treatment

and also in patients with a history of alcohol and/or drug abuse.

Use in pregnancy and lactation

Rivopam should only be administered to pregnant women if the potential benefits outweigh the risk to the fetus,

it is known that Rivopam has harmful effects on unborn child. It should not be used during breast feeding.

Driving and using machines

The patient should be informed that this medicaction may impaire the ability to drive a vehicle or operate

machine, so driving and using machine and other hazardous activities should therefore be avoided altogether or at

least during the first few days of treatment.

DRUG INTERACTIONS :

The caution should be taken when coadministration of Rivopam with the following drugs:

- Opioids or CNS depressant may result in profound sedation, respiratory depression, coma, and death.

- The antiepileptic medicines phenytoin, phenobarbital, carbamazepine, lamotrigine and valproate may increase

the clearance of clonazepam. Thereby decreasing the plasma concentration of clonazepam .

- The CNS-depressant action of the benzodiazepine class of drugs may be potentiated by alcohol, narcotics,

barbiturates, nonbarbiturate hypnotics, antianxiety agents, the phenothiazines, thioxanthene and butyrophenone

(classes of antipsychotic agents), monoamine oxidase inhibitors, the tricyclic antidepressants and by other

anticonvulsant drugs.

ADVERSE EFFECTS :

Clonazepam as other benzodiazepine drugs cause adverse effects , but not every patient get them :

-Transient effect and can be prevented by increasing the dose slowly : Dizziness, ataxia , somnolence, muscle

weakness, headache. In long term or high dose , reversible disorders may occur such as slurring of speech ,

diplopia. Rarely , nausea and GIT syptoms may occur .

- In infant and small children: increase production of saliva and bronchial hypersecretion.

- Some effects have been observed such as :Decrease platelets, allergic reaction, disturbance of concentration,

restlessness, confusion, disorientation, depression, nervousness, anxiety, sleep disturbance.

OVERDOSAGE:

Overdosage of benzodiazepines is usually ranges from drowsiness to coma. In mild cases, symptoms include

drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, dysarthria,

nystagmus, hypotonia, hypotension, respiratory depression, coma and very rarely death.

Treatment: Maintain a clear airway and adequate ventilation if indicated.

Symptomatic treatment for cardiorespiratory or central nervous system effect, treatment with activated charcoal

within 1-2 hours. Gastric lavage in case of mixed overdose where no more than one hour has elapsed since

ingestion.

If CNS depression is severe consider the use flumazenil only be administered under closely monitoring .

Hemoperfusion and hemodialysis are not useful in benzodiazepine intoxication.

STORAGE INSTRUCTIONS :

Store below 30°C, away from light.

PRESENTATIONS :

Rivopam tablets : Pack of different sizes.

Rivopam oral drops : Pack of 20 ml .

Rivopam Drops & Tabs

Section :

Rivopam Drops & Tabs

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