Afobam may be available in the countries listed below.
Ingredient matches for Afobam
Alprazolam is reported as an ingredient of Afobam in the following countries:
- Poland
International Drug Name Search
Afobam may be available in the countries listed below.
Alprazolam is reported as an ingredient of Afobam in the following countries:
International Drug Name Search
Euglucon may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Glibenclamide is reported as an ingredient of Euglucon in the following countries:
International Drug Name Search
Mixtard 50 HM may be available in the countries listed below.
Insulin Injection, Biphasic Isophane human (a derivative of Insulin Injection, Biphasic Isophane) is reported as an ingredient of Mixtard 50 HM in the following countries:
International Drug Name Search
Coretec may be available in the countries listed below.
Olprinone hydrochloride monohydrate (a derivative of Olprinone) is reported as an ingredient of Coretec in the following countries:
International Drug Name Search
Alfaciclina may be available in the countries listed below.
Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Alfaciclina in the following countries:
International Drug Name Search
Each capsule contains 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.
The inactive ingredients present are alginic acid, cellulose, D&C Red 28, FD&C Blue 1, gelatin, iron oxides, stearic acid, and titanium dioxide.
Dihydrocodeine is a semisynthetic narcotic analgesic, related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth-muscle components. The principal action of therapeutic value is analgesia.
The capsule also contains the nonnarcotic antipyretic-analgesic, aspirin.
For the relief of moderate to moderately severe pain.
Hypersensitivity to dihydrocodeine, codeine, or aspirin.
Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities.
Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, dihydrocodeine is subject to the provisions of the Federal Controlled Substances Act.
Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient using the dihydrocodeine bitartrate, aspirin, and caffeine capsule should be cautioned accordingly.
Patients receiving other narcotic analgesics, general anesthetics, tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with the dihydrocodeine bitartrate, aspirin, and caffeine capsule may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Reproduction studies have not been performed in animals. There is no adequate information on whether this drug may affect fertility in human males and females or has a teratogenic potential or other adverse effect on the fetus.
Preparations containing aspirin should be kept out of the reach of children. The dihydrocodeine bitartrate, aspirin, and caffeine capsule is not recommended for patients 12 years of age and under. Since there is no experience in children who have received this drug, safety and efficacy in children have not been established.
The dihydrocodeine bitartrate, aspirin, and caffeine capsule should be given with caution to certain patients, such as the elderly or debilitated.
The CNS-depressant effects of the dihydrocodeine bitartrate, aspirin, and caffeine capsule may be additive with that of other CNS depressants. See “WARNINGS.”
Aspirin may enhance the effects of anticoagulants and inhibit the uricosuric effects of uricosuric agents.
Clinical studies of the dihydrocodeine bitartrate, aspirin, and caffeine capsule did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.
In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.
Dosage should be adjusted according to the severity of the pain and the response of the patient. The dihydrocodeine bitartrate, aspirin, and caffeine capsule is given orally. The usual adult dose is two capsules every 4 hours as needed for pain.
Dihydrocodeine bitartrate, aspirin, and caffeine Capsules are blue and gray, marked “CP” and “419”, supplied in:
Manufactured for and distributed by:
NDC 57902-419-88
100 Capsules
Dihydrocodeine bitartrate, aspirin, and caffeine capsules
Each capsule contains: 16 mg drocode (dihydrocodeine) bitartrate (Warning–may
be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.
SEALED FOR YOUR PROTECTION
Rx Only
EUSA Pharma (USA), Inc.
| DIHYDROCODEINE BITARTRATE AND ASPIRIN AND CAFFEINE DC dihydrocodeine bitartrate and aspirin and caffeine capsule | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA011483 | 04/25/2011 | |
| Labeler - EUSA Pharma (USA), Inc. (038596862) |
B-COL may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Colistin sulfate (a derivative of Colistin) is reported as an ingredient of B-COL in the following countries:
International Drug Name Search
Lollarm may be available in the countries listed below.
Flavoxate hydrochloride (a derivative of Flavoxate) is reported as an ingredient of Lollarm in the following countries:
International Drug Name Search
Lorson may be available in the countries listed below.
Dexamethasone is reported as an ingredient of Lorson in the following countries:
Dexchlorpheniramine maleate (a derivative of Dexchlorpheniramine) is reported as an ingredient of Lorson in the following countries:
International Drug Name Search
Advovet suini may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Danofloxacin mesilate (a derivative of Danofloxacin) is reported as an ingredient of Advovet suini in the following countries:
International Drug Name Search
Bergagyn may be available in the countries listed below.
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Bergagyn in the following countries:
International Drug Name Search
In the US, Glynase (glyburide systemic) is a member of the drug class sulfonylureas and is used to treat Diabetes, Type 2.
US matches:
Glibenclamide is reported as an ingredient of Glynase in the following countries:
Glipizide is reported as an ingredient of Glynase in the following countries:
International Drug Name Search
Ritomune may be available in the countries listed below.
Ritonavir is reported as an ingredient of Ritomune in the following countries:
International Drug Name Search
Aciclosina may be available in the countries listed below.
Aciclovir is reported as an ingredient of Aciclosina in the following countries:
International Drug Name Search
Prazole may be available in the countries listed below.
Omeprazole is reported as an ingredient of Prazole in the following countries:
International Drug Name Search
Do not use if safety seal is broken
NDC 43093-102-01
Rx only
FusePaq™ Compounding Kit for Oral Suspension
Deprizine™
(ranitidine hydrochloride 16.8 mg/mL [15 mg/mL ranitidine], in oral suspension - compounding kit)
Description:
This kit contains active and inactive bulk materials to compound a ranitidine hydrochloride oral suspension. The instructions describe how to prepare 250 mL of a compounded oral suspension containing 16.8 mg/mL ranitidine hydrochloride (15 mg/mL as ranitidine). Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.
Active Ingredient:
Inactive Ingredients:
For Prescription Compounding Only
U.S. Patents Pending
CS38-A1 rev 1
Do not use if safety seal is broken
For Prescription Compounding Only
Ranitidine Hydrochloride
Net contents: 4.2 g
Repackaged by:
Fusion Pharmaceuticals, LLC
Camarillo, CA 93012
CS35-A1 rev 0
Do not use if safety seal is broken
For Prescription Compounding Only
Oral Suspension Vehicle
Sugar, dye, and paraben free
Ingredients: water, glycerin, L-glutamine, xylitol, monoammonium glycyrrhizinate, pineapple flavor, xanthan gum, stevia powder, orange flavor, citric acid, sodium citrate, potassium sorbate, sodium benzoate
Net Contents: 250 mL (8.4 fl oz)
Manufactured for:
Fusion Pharmaceuticals LLC
Camarillo, CA 93012
CS36-A1 rev 0
NDC 43093-102-01
Rx only
FusePaq™
Deprizine™
(ranitidine hydrochloride 16.8 mg/mL [15 mg/mL ranitidine], in oral suspension - compounding kit)
FusePaq™ compounding kits provide a convenient approach to rapidly compound prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP).
For Prescription Compounding Only
Description:
This kit contains active and inactive bulk materials to compound a ranitidine hydrochloride oral suspension. These instructions describe how to prepare 250 mL of a compounded oral suspension containing 16.8 mg/mL ranitidine hydrochloride (15 mg/mL as ranitidine). Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.
Contents:
Instructions for Compounding
Ranitidine hydrochloride, 16.8 mg/mL (15 mg/mL as ranitidine) oral suspension
1 Remove and Inspect the Contents of the Kit
Ensure that the safety seals are present and intact on the ranitidine hydrochloride and oral suspension vehicle bottles. If the seals are not intact, do not use the kit.
2 Prepare for Mixing
Wear gloves and eye protection during compounding operations. Remove the seal from the oral suspension bottle. Break the perforated seal and remove the cap from the ranitidine hydrochloride bottle.
3 Transfer Ranitidine Hydrochloride to the Suspension Bottle
Uncap the suspension bottle. Pour a small amount of suspension liquid (approximately one-third to one-half the volume of the ranitidine hydrochloride bottle) into the ranitidine hydrochloride bottle. Cap the ranitidine hydrochloride bottle and shake well several times to dissolve the ranitidine hydrochloride powder. Empty the contents into the suspension bottle. Cap and mix the suspension bottle. Repeat this step 3 times. Visually ensure that all of the ranitidine hydrochloride has been dissolved and transferred to the suspension bottle.
4 Complete the Mixing Process
Insert the press-in bottle adaptor into the suspension bottle. Recap the suspension bottle. Mix well by inverting repeatedly several times.
5 Re-label the Compounded Suspension
Label the compounded suspension per the pharmacy's standard practice. Remove or obscure the oral suspension vehicle label, since the label is no longer accurate once compounding is completed.
Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the mixed suspension between 2-8°C (36-46°F) . The compounded suspension is stable for at least eight weeks when stored under refrigeration, based upon real-time and accelerated stability studies.
Each lot of suspension vehicle is tested to meet microbial limits per USP Microbial Limit Test <61>. In addition, the suspension vehicle formulation has passed the USP <51> Antimicrobial Effectiveness Test.
An oral dispenser is provided in the kit and may be used to facilitate delivery of the suspension.
U.S. Patents Pending
Manufactured by:
Fusion Pharmaceuticals LLC
768 Calle Plano
Camarillo, CA 93012
CS43-A1 rev 1
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 02/08/2010 | ||
| Labeler - Fusion Pharmaceuticals LLC (021420944) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Fusion Pharmaceuticals LLC | 021420944 | manufacture | |
Ferridon may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Iron Dextran is reported as an ingredient of Ferridon in the following countries:
International Drug Name Search