PRODUCT DETAILS

 

 

Clonazepam

Action
Indications
Contraindications
Route/Dosage
Interactions
Lab Test Interferences
Adverse Reactions
Precautions Patient Care Considerations
Administration/Storage
Assessment/Interventions
Patient/Family Education

(kloe-NAY-ze-pam) Klonopin,  Rivotril Class: Anticonvulsant/Benzodiazepine

Action Potentiates action of GABA, inhibitory neurotransmitter, resulting in increased neuronal inhibition and CNS depression, especially in limbic system and reticular formation.

Indications Treatment of Lennox-Gestalt syndrome; management of akinetic and myoclonic seizures and absence seizures unresponsive to succinimides. Unlabeled use(s): Treatment of restless legs syndrome, parkinsonian dysarthria, acute manic episodes of bipolar affective disorder, multifocal tic disorders and neuralgias; adjunctive therapy for schizophrenia.

Contraindications Hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma; significant liver disease; shock; coma; acute alcohol intoxication.

Route/Dosage

ADULTS: Initial dose: PO 1.5 mg/day in 3 divided doses. Increase by 0.5–1 mg q 3 days until seizures are adequately controlled (maximum 20 mg/day). INFANTS & CHILDREN (£ 10 yr Or 30 Kg): Initial dose: PO 0.01–0.03 mg/kg/day in 2–3 divided doses. Increase by 0.25–0.5 mg q 3 days until maintenance dose of 0.1–0.2 mg/kg has been reached.

Interactions

Alcohol and CNS depressants: May cause additive CNS depressant effects. Cimetidine, oral contraceptives, disulfiram: May cause effects of clonazepam to increase, with excessive sedation and impaired psychomotor function. Digoxin: May increase serum digoxin concentrations. Omeprazole: May increase Theophylline’s: May antagonize sedative effects.

Lab Test Interferences None well documented.

Adverse Reactions

CV: Cardiovascular collapse; hypotension; phlebitis or thrombosis at intravenous sites. CNS: Drowsiness; confusion; ataxia; dizziness; lethargy; fatigue; apathy; memory impairment; disorientation; anterograde amnesia; restlessness; headache; slurred speech; aphonia; stupor; coma; euphoria; irritability; vivid dreams; psychomotor retardation; paradoxid reactions (eg, anger, hostility, mania, insomnia, muscle spasms). DERM: Rash. EENT: Visual and auditory disturbances; depressed hearing. GI: Constipation; diarrhea; dry mouth; coated tongue; excessive salivation; nausea; anorexia; vomiting. GU: Dysuria; enuresis; nocturia; urinary retention. HEMA: Blood dyscrasias including agranulocytosis; anemia; thrombocytopenia; leukopenia; neutropenia. HEPA: Hepatic dysfunction, including hepatitis and jaundice; elevated LDH, ALT, AST and alkaline phosphatase. OTHER: Dependence/withdrawal syndrome (eg, confusion, abnormal perception of movement, depersonalization, muscle twitching, psychosis, paranoid delusions, seizures).

Precautions

Pregnancy: Safety not established. Avoid drug, especially during first trimester, because of possible increased risk of congenital malformation. Not recommended during labor and delivery. Lactation: Excreted in breast milk. Children: Initial dose should be small and gradually increased. Long-term use may cause adverse effects such as possibly delayed mental or physical development. Elderly or debilitated patients: Initial dose should be small and gradually increased. Give drug with extreme care to elderly or very ill patients with limited respiratory reserve. Psychiatric disorders: Not intended for use in patients with primary depressive disorder, psychosis or disorders in which anxiety is not prominent. Renal or hepatic impairment: Use drug with caution to avoid accumulation. Seizure: In patients with multiple seizure types, drug may increase incidence or precipitate onset of grand mal seizures. Suicide: Use drug with caution in patients with suicidal tendencies; do not allow patient access to large quantities.

PATIENT CARE CONSIDERATIONS

Administration/Storage

• Give with food or milk to decrease GI upset.
• Do not administer with antacid; give at least 1 hr. apart.
• If possible, divide daily dose into three equal doses. If doses are unequal, give largest dose at bedtime.
• Parenteral administration should be reserved primarily for acute states.
• Observe patient for up to 3 hr. after parenteral administration.
• Do not inject drug intra-arterially; intra-arterial injection may produce arteriospasm that can lead to gangrene.
• Store at room temperature.

Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Assess renal studies: urinalysis, BUN, urine creatinine.
• Assess blood studies (CBC and platelets) prior to and regularly throughout therapy.
• Evaluate hepatic studies: ALT, AST, bilirubin, creatinine, alkaline phosphatase.
• Patient should undergo ophthalmic examination before, during and after therapy.
• Observe for drowsiness, ataxia, confusion, especially in elderly or debilitated patient.
• Drowsiness and dizziness may occur early in therapy; assist with ambulation, use side rails.
• Provide gum, hard candy and frequent sips of water to relieve dry mouth.
• Because of risk of apnea and cardiac arrest, resuscitative facilities should be available.
• Monitor drug levels during therapy. Therapeutic level is 20–80 mg/ml.
• Monitor for blood dyscrasias: observe for fever, sore throat, bruising, rash, jaundice.
• Monitor mental status: mood, sensorium, affect, over sedation, sleep pattern, drowsiness, behavioral changes (especially in children; eg, inattention in school). Report changes to physician.
• Monitor seizure activity and record. Take seizure precautions as needed.
• Abrupt withdrawal, particularly in long-term, high-dose therapy, may cause status epilepticus, vomiting, diarrhea, and sweating; monitor patient carefully.

OVERDOSAGE: SIGNS & SYMPTOMS Somnolence, confusion, diminished reflexes, coma

 Patient/Family Education

• Instruct patient to take drug with food or milk to decrease GI upset.
• Tell patient not to take drug within 1 hr. of antacid.
• Instruct patient to keep record of seizure activity and report to physician.
• Encourage patient to carry identification card or Medi-Alert bracelet that indicates diagnosis and drug dosage.
• If patient is child, advise parents to supervise child’s play and watch for inattention.
• Caution patient not to stop taking medication abruptly.
• Advise patient to contact physician immediately if serious side effects (eg, changes in mental status) occur.
• Instruct patient to rise slowly or fainting may occur, especially in elderly patients.
• Advise patient to avoid intake of alcoholic beverages or other CNS depressants.
• Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.

INTRODUCTION

RIVOTRIL 2MG TABLET contains Clonazepam which belongs to the group of medicines known as Benzodiazepines. It is used to treat seizure disorder (epilepsy) in adults and children and panic disorder with or without fear of open spaces (agoraphobia) in adults.

Epilepsy is a common condition affecting the brain and causes frequent fits or seizures (bursts of electrical activity in the brain). Symptoms include uncontrollable jerking or shaking, loss of consciousness or collapse. Panic disorder is characterized by the sudden occurrence of panic attacks or fear.

During the therapy with RIVOTRIL 2MG TABLET, your doctor may conduct a blood test to determine liver function. Do not consume alcohol while taking RIVOTRIL 2MG TABLET as it may provoke seizures or fits and may worsen side effects which may possibly lead to severe sedation.

RIVOTRIL 2MG TABLET is not recommended for use in patients with myasthenia gravis, acute narrow-angle glaucoma, sleep apnea, lung diseases and breathing problems, and severe liver diseases. Consult your doctor before taking it.

RIVOTRIL 2MG TABLET should be taken with caution in patients with mild to moderate liver disease, severe kidney disease, low blood pressure, depression, psychosis and schizophrenia. Consult your doctor before taking it.

RIVOTRIL 2MG TABLET is not recommended for use in pregnant women unless considered clearly necessary. Consult your doctor before taking it. RIVOTRIL 2MG TABLET is generally not recommended for use in breastfeeding women unless considered clearly necessary as it may pass through the breast milk. Consult your doctor before taking it.

RIVOTRIL 2MG TABLET should be used with caution in children and elderly patients. Consult your doctor before taking it.

Some severely specific side effects of RIVOTRIL 2MG TABLET include suicidal thoughts or thoughts of self-harming or unusual changes in behavior or mood. If you have these thoughts, contact your doctor immediately.

The most common side effects of taking RIVOTRIL 2MG TABLET are drowsiness, dizziness, problems with walking and coordination, depression, fatigue, and problems with memory. Contact your doctor in case any of the symptoms worsen.