Clonazepam chemical structure
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Clonazepam

Clonazepam (marketed by Roche under the trade-name Klonopin® in the United States and Rivotril® in Canada and Europe) is a drug which is a benzodiazepine derivative. It is a highly potent and powerful sedative, hypnotic, anticonvulsant, amnestic and anxiolytic. more...

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Pharmacology

Like other benzodiazepines, clonazepam is believed to act by simulating the action of GABA on the central nervous system. Because of strong anxiolytic properties and euphoriant side-effects it is said to be among the class of 'highly potent' benzodiazepines with a higher risk of abuse, misuse and dependence than other benzodiazepines. The sedative effects of Clonazepam are relatively weak, compared to its strong anxiolytic and anticonvulsant effects. One quarter of a milligram (0.25mg) of Clonazepam is equivalent to five milligrams (5.00mg) of Diazepam.

Indications

Clonazepam is commonly prescribed for:

  • Epilepsy
  • Anxiety disorder
  • Panic attacks
  • Restless leg syndrome (RLS)
  • Inital treatment of mania, together with firstline-drugs such as lithium, haloperidol or risperidone
  • Hallucinogen persisting perception disorder (off-label use)
  • Chronic fatigue syndrome
  • Night terrors

Clonazepam is rarely used as a treatment for insomnia, because its sedative effects are relatively weak compared to other benzodiazepines.

Availability

Clonazepam was approved in the United States as a generic medication in 1997 and is now manufactured and marketed by several companies.

Clonazepam is available in the following forms:

  • Tablets: 0.25, 0.5, 1.0, and 2mg
  • Liquid concentrate: 2.5mg per ml
  • Oral wafers: 0.25, 0.5, 1.0 mg
  • Injection concentrate: 1mg per ml

Dosage

Epilepsy

Status epilepticus - 1mg is given slowly by I.V.; if seizures persist additional doses of 1mg may be given in intervals of 10 to 20 minutes.

Clonazepam can be useful for long-term treatment of some petit-mal forms of epilepsy in children and adolescents (adults may also respond well).

Up to 30% of epileptic patients treated with clonazepam develop a serious tolerance to the anticonvulsant effects. This may require dose increases or gradual withdrawal and replacement of the drug.

Oral doses in long term treatment of epilepsy vary from 1mg to 20mg, depending upon the severity of case and the weight of the patient. Treatment should be initiated at a low dose, and can be increased gradually if necessary.

Other

  • Anxiety and panic disorders - 1mg to 10mg daily, in divided doses
  • Restless Leg Syndrome - 1mg to 2mg at bedtime
  • Mania - Up to 20mg daily, in divided doses

Side Effects

Because Clonazepam can impair both mental and motor function, those taking it are advised to use caution when operating motor vehicles or machinery, or engaging in hazardous occupations requiring mental alertness. Side effects include:

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Clonazepam 0.1-mg/mL Oral Liquid
From International Journal of Pharmaceutical Compounding, 11/1/05

METHOD OF PREPARATION

1. Calculate the required quantity of each ingredient for the total amount to be prepared.

2. Accurately weigh and/or measure each ingredient.

3. If tablets are used, pulverize the tablets to a fine powder, or use bulk clonazepam powder.

4. Slowly add the Ora-Plus and mix, forming a smooth paste and then a uniform suspension.

5. Slowly add the Ora-Sweet, Ora-Sweet SF, or cherry syrup to volume and mix well.

6. Package and label.

PACKAGING

Package in tight, light-resistant containers.

LABELING

Keep out of reach of children. Use only as directed. Shake well before using. Protect from light.

STABILITY

A beyond-use date of 60 days can be used for this preparation.1,2

USE

Clonazepam oral liquid has been used in the management of various seizure conditions.

QUALITY CONTROL

Quality-control assessment can include weight/volume, pH (pH of 4 to 4.4 using the "Ora" family of vehicles and 2.5 to 3.3 using cherry syrup), specific gravity, active drug assay, color, rheological properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).3

DISCUSSION

Clonazepam is a benzodiazepine anticonvulsant that is structurally and pharmacologically related to diazepam and other benzodiazepines. It is well absorbed from the gastrointestinal tract. Uses of clonazepam include the prophylactic management of LennoxGastaut syndrome and akinetic and myoclonic seizures. It also may be used in the management of petit mal seizures that are unresponsive to succinimides.4

Clonazepam USP (C^sub 15^H^sub 10^ClN^sub 3^O^sub 3^, MW 315.71, Klonopin) occurs as a light-yellow powder with a faint odor. It is insoluble in water and slightly soluble in alcohol.2 It is available as 0.5-, 1-, and 2-mg tablets that also contain lactose, magnesium stearate, microcrystalline cellulose, and cornstarch. The 0.5-mg tablets contain FD&C Yellow No. 6 Lake, and the 1-mg tablets contain FD&C Blue No. 1 Lake and FD&C Blue No. 2 Lake.5

Ora-Plus is an oral suspending vehicle with a pH of approximately 4.2 and an osmolality of about 230 mOsm/kg. It is thixotropic, with a viscosity of approximately 1,000 cps at 25°C. It contains purified water, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, sodium phosphate and citric acid as buffering agents, simethicone as an antifoaming agent, and potassium sorbate and methylparaben as preservatives.6

Ora-Sweet syrup is a flavoring vehicle for oral extemporaneous preparations. It has a citrus-berry flavor blend and contains glycerin and sorbitol to prevent "cap-lock" problems associated with many syrups. It is buffered to a pH of approximately 4.2 and has an osmolality of about 3,240 mOsm/kg. It contains purified water, sucrose, glycerin, sorbitol (5%), flavoring, sodium phosphate and citric acid as buffering agents, and potassium sorbate and methylparaben as preservatives.7

Ora-Sweet SF sugar-free, alcohol-free syrup is a flavoring vehicle for oral extemporaneous preparations. It has a citrus-berry flavor blend. It is buffered to a pH of approximately 4.2 and may be used alone or in combination with other vehicles. It will tolerate a dilution to 50% with dissolved actives in water or suspending agents and still retain an acceptable taste. It has an osmolality of 2,150 mOsm/kg. It contains water, sodium saccharin, xanthan gum, glycerin, and sorbitol; citric acid and sodium citrate as buffers; methylparaben, propylparaben, and potassium sorbate as preservatives; and flavoring agents.8

Cherry Syrup NF consists of cherry juice (475 mL), sucrose (800 g), alcohol (20 mL), and purified water (to make 1000 mL). It should be preserved in tight, light-resistant containers. Exposure to excessive heat should be prevented. It should be labeled to state the Latin binomial name and, following the official name, the part of the plant source from which it was derived. It contains from 1.0% to 2.0% alcohol. It is used as an oral vehicle.2

References

1. Allen LV Jr, Erickson MA III. Stability of acetazolamide, allopurinol, azathioprine, clonazepam, and flucytosine in extemporaneously compounded oral liquids. Am J Health Syst Pharm 1996; 53(16): 1944-1949.

2. US Pharmacopeial Convention, Inc. USP-Pharmacists' Pharmacopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005: 362, 408-431, 678.

3. Allen LV Jr. Standard operating procedure for quality assessment of oral and topical liquids. IJPC 1999; 3(2): 146-147.

4. McEvoy GK, ed. AHFS Drug Information-2005. Bethesda, MD: American Society of Health-Systems Pharmacists; 2005: 2124-2126.

5. [No author listed.] Physicians' Desk Reference. 58th ed. Montvale, NJ: Thomson PDR; 2004: 2920-2923.

6. Ora-Plus [product information]. Minneapolis, MN: Paddock Laboratories, Inc.

7. Ora-Sweet [product information]. Minneapolis, MN: Paddock Laboratories, Inc.

8. Ora-Sweet SF [product information], Minneapolis, MN: Paddock Laboratories, Inc.

Copyright International Journal of Pharmaceutical Compounding Nov/Dec 2005
Provided by ProQuest Information and Learning Company. All rights Reserved

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