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Alprazolam is a short-acting benzodiazepine used to treat anxiety disorders. It is generally sold in generic form (i.e., alprazolam) in the United States (to cut down on costs for insurance companies) and also under many other brand names, depending on the country: more...
- Xanax® - United States, Australia, United Kingdom
- Xanax XR® - (an extended release formulation) United States
- Apotex® - Canada
- Xanor® - Finland, Philippines, South Africa, Sweden
- Kalma® - Australia, New Zealand
- Ralozam® - Australia, New Zealand
- Zamhexal® - Australia
- Alplax® - Argentina
- Alviz® - Indonesia
- Alzolam® - India, Malaysia
- Alprax® - India
- Tranax® - India
- Restyl® - Bahrain, Cyprus, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic of Yemen, Saudi Arabia, Syria, United Arab Emirates
- Tranquinal® - Ecuador, Peru
- Trankimazin® - Spain
- Tafil® - Costa Rica, Denmark, El Salvador, Germany, Guatemala, Honduras, Mexico, Nicaragua, Panama, Venezuela
- Tafil AP® - (an extended release formulation) Mexico
- Constan® - Japan
- Solanax® - Japan
- Zolarem® - Bahrain, Benin, Burkina-Faso, Cyprus, Egypt, Ethiopia, Gambia, Ghana, Guinea, Iran, Iraq, Israel, Ivory Coast, Jordan, Kenya, Kuwait, Lebanon, Liberia, Libya, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Oman, Qatar, Republic of Yemen, Saudi Arabia, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Syria, Tanzania, Tunia, Uganda, United Arab Emirates, Zambia, Zimbabwe
- Zoldac® - Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, India, Ivory Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe
Alprazolam has a calming effect, with the most common side effects being drowsiness, clumsiness, and to a lesser extent, fatigue, and headache. It can also have more adverse effects, such as blurred vision, slurred speech or dysarthria, and changes in personality. It may be habit forming and users often develop a tolerance to its initial effects, although its anxiolytic efficacy remains intact. Physical and/or psychological dependence may develop after several weeks of alprazolam treatment. There is now a general consensus among many psychiatrists that alprazolam (a so-called 'high-potency' benzodiazepine) poses a particularly high risk for abuse and dependence. Withdrawal after long-term use should be done slowly over a period of weeks to avoid serious withdrawal symptoms such as agitation, rebound anxiety, muscle cramps and possible seizures. Some patients may benefit from a more gradual dosage reduction and/or discontinuation and substitution with diazepam.
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|Alprazolam 1-mg/mL Oral Liquid|
From International Journal of Pharmaceutical Compounding,
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 alprazolam 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.
Package in tight, light-resistant containers.
Keep out of reach of children. Use only as directed. Shake well before taking. Protect from light.
A beyond-use date of 60 days is appropriate for this preparation.1,2
Generally, alprazolam is a sedative-hypnotic. It has been used in the management of anxiety disorders, for the short-term relief of symptoms of anxiety or anxiety associated with depressive symptoms, and for the management of panic disorder.3
Quality-control assessment can include weight/volume, pH (pH 4.2 to 4.7 if the "Ora" family of vehicles is used, or 3.4 to 4.2 in cherry syrup), specific gravity, active drug assay, color, rheological properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).4
Alprazolam is often prepared in oral liquid dosage forms for children and elderly patients who cannot accommodate the solid tablets or when the exact dosage is not available in tablet form. In compounding this preparation, the pharmacist can use either the commercial tablet or the bulk powder. Alprazolam has the typical benzodiazepine actions.3
Alprazolam USP (C^sub 17^H^sub 13^ClN^sub 4^, MW 308.76, Xanax) occurs as a white to off-white, crystalline powder that melts at about 225°C. It is insoluble in water and soluble in alcohol.2 Alprazolam, a benzodiazepine, is commercially available as 0.25-, 0.5-, 1-, and 2-mg tablets. The Xanax brand tablets also contain cellulose, cornstarch, docusate sodium, lactose, magnesium stearate, silicon dioxide, and sodium benzoate. The 0.5-mg tablets contain FD&C Yellow No. 6, and the 1-mg tablets contain FD&C Blue No. 2.5
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 citrus-berry-flavored vehicle for oral extemporaneous preparations. 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 is a sugar-free, alcohol-free syrup with 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 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
1. Allen LV Jr, Erickson MA III. Stability of alprazolam, chloroquine phosphate, cisapride, enalapril maleate, and hydralazine hydrochloride in extemporaneously compounded oral liquids. Am J Health Syst Pharm 1998; 55(18): 1915-1920.
2. US Pharmacopeial Convention, Inc. USP-Pharmacists' Pharmacopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005: 362,408-431, 668.
3. McEvoy GK, ed. AHFS Drug Information-2005. Bethesda, MD: American Society of Health-Systems Pharmacists; 2005: 2404.
4. Allen LV Jr. Standard operating procedure for quality assessment of oral and topical liquids. IJPC1999; 3(2): 146-147.
5. [No author listed.] Physicians' Desk Reference. 58th ed. Montvale, NJ: Thomson PDR; 2004: 2798-2802.
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
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