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Lorazepam

Lorazepam (marketed under the brand names Ativan®, Temesta®, Tavor®) is a drug which is a benzodiazepine derivative. Pharmacologically, it is classified as a sedative-hypnotic, anxiolytic and anticonvulsant. more...

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Pharmacology and pharmacokinetics

Lorazepam is rapidly and nearly completely absorbed after any mode of application (oral, sublingual, i.m., i.v.). The onset of action is several minutes after i.v. injections, 30 to 45 minutes after oral/sublingual administration, and up to 1 hour after i.m. injections.

The duration of action depends on the dose, and is normally 6 to 12 hours. The half-life of lorazepam in patients with normal liver function is 11 to 18 hours. Therefore, 2 to 4 daily doses are often needed.

0.5mg (500µg) of lorazepam is equivalent to 5mg of diazepam . Other experts estimate a proportion of 1mg lorazepam to 5mg diazepam.

Indications

Lorazepam is indicated for:

Treatment of anxiety disorders
Short-term treatment of insomnia, particularly if associated with severe anxiety
Treatment of symptoms associated with alcohol withdrawal
As a premedication,
- To facilitate unpleasant procedures, such as endoscopies and dental surgery.
- To augment the action of the primary anaesthetic drug.
- To produce varying degrees of anterograde amnesia for the duration of the procedure.
Long-term treatment of otherwise resistant forms of petit mal epilepsy
Acute therapy of status epilepticus
Acute therapy of catatonic states alone/or with haloperidol
As an initial adjunctive treatment for depressions, mania and psychosis
Treatment of acute delirium, preferrably together with haloperidol
Supportive therapy of nausea/emesis frequently associated with cancer chemotherapy, usually together with firstline antiemetics like 5-HT3-antagonists

Lorazepam is available in tablets and as a solution for intramuscular and intravenous injections. It is also available as a parenteral patch.

Dosage

Daily doses vary greatly from 0.5 mg bedtime for insomnia and 2.5 mg every 6 hours and more in the acute treatment of mania, before the firstline drugs (lithium, valproic acid) control the situation.

Catatonia with inability to speak is very responsive and sometimes controlled with a single dose of 2 mg oral or slow i.v. injection. Catatonia may reoccur and treatment for some days may be necessary. Sometimes haloperidol is given concomitantly.

The control of status epilepticus requires slow i.v. injections of 2 to 4 (or even 8) mg. Patients should be closely monitored for respiratory depression and hypotensive effects.

In any case, dose requirements have to be individualized especially in the elderly and debilitated patients in whom the risk of oversedation is greater. Safety and effectiveness of lorazepam is not well determined in children under 18 years of age, but it is used to treat serial seizures. With higher doses (preferably i.v.-doses) the patient is frequently not able to recall unpleasant events (anterograde amnesia) such as therapeutic interventions (endoscopies etc.), which is a desirable effect. But in these cases the risk is given that a patient later makes unjustified allegations of sexual abuse during treatment due to poor recall.

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Lorazepam 2-mg sublingual tablets
From International Journal of Pharmaceutical Compounding, 3/1/03

METHOD OF PREPARATION

Note: Calibrate the mold to be used with this base prior to preparing the tablet triturates for the first time. Also, the ratio of lactose:sucrose and ethanol:water can be varied for the desired hardness and release of the sublingual tablets.

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

2. Accurately weigh and/or measure each ingredient.

3. Mix the lorazepam, lactose, and sucrose until uniform.

4. Moisten the powders with a 1:1 mixture of the alcohol: water mixture until a dough consistency is obtained.

5. Separate the mold and place the cavity plate on a hard surface, such as a pill tile.

6. Press the drug mixture into the cavities until uniform and firm.

7. Place the cavity plate over the peg plate of the mold and gently press the cavity plate down over the pegs, leaving the formed tablets on top of the pegs.

8. Allow the tablets to air dry.

9. Remove the tablets carefully.

10. Package and label.

PACKAGING

Package in a well-closed, light-resistant container.

LABELING

Use only as directed. Keep out of reach of children.

STABILITY

These tablets should be stable for up to 6 months.1

USE

Lorazepam su lingual tablets are used in the treatment of anxiety disorders or for the short-term relief of symptoms of anxiety or anxiety associated with depressive symptoms.2

QUALITY CONTROL

Quality-control assessment can include average tablet weigh, actual yield compared to theoretical yield, and physical observation.

DISCUSSION

Lorazepam (C^sub 15^H^sub 10^C^sub 12^, N^sub 2^O^sub 2^, MW 321.16) occurs as a white or practically white, practically odorless powder. It is insoluble in water and sparingly soluble in alcohol. It should be stored in tight, light-resistant containers. It melts at about 173 deg C, and has pK^sub a^ values of 1.3 and 11.5, and an octanol/pH 7.4 buffer partition coefficient of 2.4.

Lactose, anhydrous (C^sub 12^H^sub 22^O^sub11^, MW 342.30); lactose monohydrate (C^sub 12^H^sub 22^O^sub 11^ * H^sub 2^O, MW 360.31); (milk sugar, saccharum lactis) is available either anhydrous or as the monohydrate. Commercially, it is available as anhydrous alpha-lactose, alpha-lactose monohydrate, and anhydrous beta-lactose; it is available in different grades and different particle characteristics. It is widely used as a diluent in numerous dosage forms, and in lyophilized products and infant formulas. It is soluble in water to the extent of about 1 g in 4.63 mL but is practically insoluble in ethanol.3

Sucrose (beet sugar, cane sugar, refined sugar, saccharose) is obtained from sugar cane, sugar beet, or other sources. It contains no added substances. It occurs as colorless crystals, crystalline masses or blocks, or as a white, crystalline powder that is odorless and has a sweet taste. It has a melting range of 160 deg C to 186 deg C with some decomposition. Sucrose is soluble in water (1 g in 0.5 mL), alcohol (1 g in 400 mL), and 95% ethanol (1 g in 170 mL), and is practically insoluble in chloroform. Sucrose is stable at room temperature.4

Alcohol (ethyl alcohol, ethanol, grain alcohol) is a clear, colorless mobile and volatile liquid with a slight, characteristic odor and a burning taste. Alcohol USP refers to 95% ethanol, and dehydrated alcohol refers to 99.5 % alcohol. The specific gravity of Alcohol USP is between 0.812 and 0.816 and its boiling point is 78.15 deg C. It is miscible with chloroform, glycerin, and water and its solutions may be sterilized by autoclaving or by filtration. It should be stored in a cool place.5

Purified water is water that is obtained by distillation, ion exchange, reverse osmosis, or some other suitable process. Water has a specific gravity of 0.9971 at room temperature, a melting point at O deg C, and a boiling point at 100 deg C. It is miscible with most polar solvents and is chemically stable in all physical states (ice, liquid, and steam).6

References

1. United States Pharmacopeial Convention, Inc. United States Pharmacopeia 25/National Formulary 20. Rockville, MD:US Pharmacopeial Convention, Inc; 2002:1021, 2053-2057, 2383.

2. McEvoy GK. AHFS Drug Information-2002. Bethesda, MD:American Society of Health-System Pharmacists; 2002:2394-2396.

3. Kibbe AH. Lactose. In: Kibbe A, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:276-285.

4. Hamlow EE, Armstrong NA, Pickard A. Sucrose. In: Kibbe A, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:539-543.

5. Weller PJ. Alcohol. In: Kibbe A, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:7-9.

6. Ellison A, Nash RA, Wilkin MJ. Water. In: Kibbe A, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:580-584.

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