Efam may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Efam in the following countries:
International Drug Name Search
Natelle® Complete capsules for oral administration are supplied as oblong pink soft gelatin capsules, imprinted with "nComplete" in white ink.
Each capsule contains:
Docosahexaenoic Acid (DHA) from Algal Oil.........................................................250 mg
Eicosapentaenoic Acid (EPA) ....................................................... Not more than 0.625 mg
Calcium (Tricalcium Phosphate).................................................................................100 mg
Iron (Ferrous Fumarate) .................................................................................................30 mg
Vitamin C (Ascorbic Acid) ............................................................................................30 mg
Vitamin B-6 (Pyridoxine HCl) .........................................................................................25 mg
Vitamin E (D-Alpha Tocopherol)...................................................................................... 30 IU
Folic Acid ...........................................................................................................................1 mg
Vitamin D (Cholecalciferol) ........................................................................................... 400 IU
DHA is an omega-3 fatty acid. The DHA in Natelle® Complete is derived from Algal Oil (C. cohnii).
Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin, D&C Red #33, FD&C Red#40.
Natelle® Complete is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non–lactating mothers, and throughout the childbearing years. Natelle® Complete may be beneficial in improving the nutritional status of women prior to conception.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.
Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Other sources of folic acid are leafy vegetables, fortified cereals and bread. Causes of neural tube defect are multifactorial and folic acid supplements alone may not prevent these birth defects.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
One capsule daily, or as directed by a physician.
Supplied in child resistant bottles of 30 capsules (NDC 18860-652-01).
Store at controlled room temperature 15°-30°C (59°-86°F).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Distributed by: AZUR PHARMA, INC. •1818 Market Street, Suite 2350 • Philadelphia, PA 19103 • www.azurpharma.com
To report a serious adverse event or obtain product information, contact (800) 890 3098.
life’sDHA™ is a trademark of Martek Biosciences Corporation.
Natelle® is a registered trademark of Pharmelle.
Rx Only
NTCMw-10-01
Physician Starter Kit Front Carton Label
natelle® COMPLETE
All-in-one Rx prenatal vitamin with
plant-based DHA
A complete formulation for you and your baby.
Distributed by: AZUR PHARMA, INC.
1818 Market Street, Suite 2350 ∙ Philadelphia, PA 19103
www.azurpharma.com
Manufactured by: Accucaps Industries Ltd.
Windsor, Ontario, Canada
Natelle® is a registered trademark of Pharmelle.
life'sDHA™ is a trademark of Martek Biosciences Corporation.
Physician Starter Kit Left-Side Carton Label
natelle® COMPLETE
All-in-one Rx prenatal vitamin with
plant-based DHA
NDA 18860-652-00
ONE PHYSICIAN SAMPLING KIT
Contains 10 Patient Starter Kits,
each containing 3 capsules
NOT FOR SALE
RX ONLY
Bottle Label
30 CAPSULES
18860-652-01
Rx Only
natelle®
COMPLETE
All-in-one Rx prenatal vitamin with
plant-based DHA
Dist by: AZUR PHARMA, INC.
1818 Market Street, Suite 2350
Philadelphia, PA 19103
www.azurpharma.com
Mfg by: Accucaps Industries, Ltd.
Windsor, Ontario, Canada
To report a serious adverse event or obtain
product information, contact (800) 890 3098.
Natelle® is a registered trademark of Pharmelle.
life'sDHA™ is a trademark of Martek Biosciences Corporation.
| Natelle Complete docosahexaenoic acid, eicosapentaenoic acid, calcium, iron, vitamin c, vitamin b-6, vitamin e, folic acid and vitamin d capsule, gelatin coated | |||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 06/24/2011 | ||
| Labeler - Azur Pharma, Inc. (805611071) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Accucaps Industries Limited | 248441727 | MANUFACTURE | |
Glimepiride Teva may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimepiride Teva in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Omeprazole is reported as an ingredient of Gastrogard in the following countries:
International Drug Name Search
Isosorbidedinitraat PCH may be available in the countries listed below.
Isosorbide Dinitrate is reported as an ingredient of Isosorbidedinitraat PCH in the following countries:
International Drug Name Search
Generic Name: hydroxyurea (hye DROX ee yoo REE a)
Brand names: Droxia, Hydrea, Mylocel
Hydroxyurea affects certain cells in the body, such as cancer cells or sickled red blood cells.
Hydroxyurea is used to treat chronic myelocytic leukemia, ovarian cancer, and certain types of skin cancer (melanoma and primary squamous cell cancer of the head and neck).
Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia.
Hydroxyurea may also be used for purposes not listed in this medication guide.
Before using hydroxyurea, tell your doctor if you have bone marrow suppression, HIV or AIDS, liver or kidney disease, or if you are receiving chemotherapy or radiation.
If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.
Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.
severe bone marrow suppression;
severe anemia; or
low levels of platelets in your blood.
To make sure you can safely take hydroxyurea, tell your doctor if you have any of these other conditions:
bone marrow suppression;
HIV or AIDS;
if you are receiving chemotherapy or radiation.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Hydroxyurea is either taken once per day or once every third day, depending on the condition being treated. On each of your dosing days, take the medicine at the same time of day. Your doctor may also want you to take a folic acid supplement. Follow your doctor's instructions very carefully.
If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.
Hydroxyurea can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.
To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.
Use hydroxyurea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
See also: Hydroxyurea dosage (in more detail)
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include drowsiness, mouth sores, and swelling with pain and purple discoloration in your hands and feet.
Do not handle hydroxyurea pills or the medicine bottle without skin protection (disposable gloves).
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
skin redness, skin ulcers, or open sores;
painful or difficult urination;
confusion, hallucinations, seizure; or
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).
Less serious side effects may include:
hair loss;
skin peeling or discoloration, mild rash;
upset stomach, constipation, diarrhea;
headache, dizziness; or
weight gain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Solid Tumors:
Solid Tumors:
Intermittent Therapy: 80 mg/kg administered orally as a single dose every third day.
Continuous Therapy: 20 to 30 mg/kg administered orally as a single dose daily.
Concomitant Therapy with Irradiation: Carcinoma of the head and neck: 80 mg/kg administered orally as a single dose every third day.
Administration of hydroxyurea should be begun at least seven days before initiation of irradiation and continued during radiotherapy as well as indefinitely afterwards provided that the patient may be kept under adequate observation and there is no evidence of unusual or severe reactions.
Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures such as topical anesthetics and orally administered analgesics. If the reaction is severe, hydroxyurea therapy may be temporarily interrupted; if it is extremely severe, irradiation dosage may, in addition, be temporarily postponed. However, it has rarely been necessary to terminate these therapies.
Severe gastric distress, such as nausea, vomiting, and anorexia, resulting from combined therapy may usually be controlled by temporary interruption of hydroxyurea administration.
Usual Adult Dose for Sickle Cell Anemia:
Initial Dose: 15 mg/kg (10-20 mg/kg) once a day. The dose may be increased in 5 mg/kg/day increments every 12 weeks to a maximum dose of 35 mg/kg/day.
Usual Adult Dose for Chronic Myelogenous Leukemia:
Resistant Chronic Myelocytic Leukemia: Until the intermittent therapy regimen has been evaluated, continuous therapy at 20 to 30 mg/kg administered orally as a single dose daily is recommended.
An adequate trial period for determining the antineoplastic effectiveness of hydroxyurea is six weeks of therapy. When there is regression in tumor size or arrest in tumor growth, therapy should be continued indefinitely.
Therapy should be interrupted if the white blood cell count drops below 2500/mm3, or the platelet count below 100,000/mm3. In these cases, the counts should be rechecked after three days, and therapy resumed when the counts rise significantly toward normal values. Since the hematopoietic rebound is prompt, it is usually necessary to omit only a few doses. If prompt rebound has not occurred during combined hydroxyurea tablets and irradiation therapy, irradiation may also be interrupted. However, the need for postponement of irradiation has been rare. Radiotherapy has usually been continued using the recommended dosage and technique. If severe anemia occurs, it should be corrected without interrupting hydroxyurea therapy. Because hematopoiesis may be compromised by extensive irradiation or by other antineoplastic agents, it is recommended that hydroxyurea be administered cautiously to patients who have recently received extensive radiation therapy or chemotherapy with other cytotoxic drugs.
Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures such as topical anesthetics and orally administered analgesics. If the reaction is severe, hydroxyurea therapy may be temporarily interrupted; if it is extremely severe, irradiation dosage may, in addition, be temporarily postponed. However, it has rarely been necessary to terminate these therapies.
Severe gastric distress, such as nausea, vomiting, and anorexia, resulting from combined therapy may usually be controlled by temporary interruption of hydroxyurea administration.
Some medicines can increase your risk of certain side effects while taking hydroxyurea. Tell your doctor if you are also using:
didanosine (Videx);
stavudine (Zerit); or
an interferon such as Actimmune, Alferon, Avonex, Betaseron, Extavia, Infergen, Intron, Rebetron, Rebif, or Roferon.
This list is not complete and other drugs may interact with hydroxyurea. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: hydroxyurea side effects (in more detail)
Gastro may be available in the countries listed below.
Famotidine is reported as an ingredient of Gastro in the following countries:
International Drug Name Search
Glimepirida may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimepirida in the following countries:
International Drug Name Search
GF may be available in the countries listed below.
Gatifloxacin is reported as an ingredient of GF in the following countries:
International Drug Name Search
Glimepirida Alter may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimepirida Alter in the following countries:
International Drug Name Search
Metvixia is a brand name of methyl aminolevulinate topical, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Metvixia available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Metvixia. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Rheohes may be available in the countries listed below.
Hetastarch is reported as an ingredient of Rheohes in the following countries:
International Drug Name Search
Gabapentin-biomo may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentin-biomo in the following countries:
International Drug Name Search
Ultrazole may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Ultrazole in the following countries:
International Drug Name Search
Testosterone cypionate injection, USP, for intramuscular injection, contains Testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone Testosterone.
Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.
The chemical name for Testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.
The structural formula is represented below:
Testosterone cypionate injection, USP is available in two strengths, 100 mg/mL and 200 mg/mL Testosterone cypionate.
Each mL of the 100 mg/mL solution contains:
| Testosterone cypionate | 100 mg |
| Benzyl benzoate | 0.1 mL |
| Cottonseed oil | 736 mg |
| Benzyl alcohol (as preservative) | 9.45 mg |
Each mL of the 200 mg/mL solution contains:
| Testosterone cypionate | 200 mg |
| Benzyl benzoate | 0.2 mL |
| Cottonseed oil | 560 mg |
| Benzyl alcohol (as preservative) | 9.45 mg |
Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorous, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.
Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.
During exogenous administration of androgens, endogenous Testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).
There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.
Testosterone esters are less polar than free Testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, Testosterone cypionate can be given at intervals of two to four weeks.
Testosterone in plasma is 98 percent bound to a specific Testosterone-estradiol binding globulin, and about 2 percent is free. Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of Testosterone between free and bound forms, and the free Testosterone concentration will determine its half-life.
About 90 percent of a dose of Testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of Testosterone and its metabolites; about 6 percent of a dose is excreted in the feces, mostly in the conjugated form. Inactivation of Testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways.
The half-life of Testosterone cypionate when injected intramuscularly is approximately eight days.
In many tissues the activity of Testosterone appears to depend on reduction to dihydroTestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.
Testosterone cypionate injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous Testosterone.
Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued.
Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis – all potentially life-threatening complications.
Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.
Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.
Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.
This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.
This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.
Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.
Testosterone cypionate should not be used interchangeably with Testosterone propionate because of differences in duration of action.
Testosterone cypionate is not for intravenous use.
Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.
Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.
Serum cholesterol may increase during androgen therapy.
Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.
Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
Androgens may decrease levels of thyroxinebinding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of Testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.
Pregnancy Category X. (See CONTRAINDICATIONS.)
Testosterone cypionate injection, USP is not recommended for use in nursing mothers.
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
The following adverse reactions in the male have occurred with some androgens:
Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
Hirsutism, male pattern of baldness, seborrhea, and acne.
Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS).
Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
Hypersensitivity, including skin manifestations and anaphylactoid reactions.
Inflammation and pain at the site of intramuscular injection.
Testosterone is a controlled substance under the Anabolic Steroid Control Act, and Testosterone cypionate injection, USP has been assigned to Schedule III.
There have been no reports of acute overdosage with the androgens.
Testosterone cypionate injection, USP is for intramuscular use only.
It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.
The suggested dosage for Testosterone cypionate injection, USP varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions.
Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.
For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.
Testosterone cypionate injection, USP is available as follows:
100 mg/mL:
NDC 0781-3073-70 – 10 mL multidose vial
200 mg/mL:
NDC 0781-3074-71 – 1 mL vial
NDC 0781-3074-70 – 10 mL multidose vial
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.
03-2009M
U1006824
Manufactured in Canada by
Sandoz Canada Inc. for
Sandoz Inc., Princeton, NJ 08540
NDC 0781-3073-70
Testosterone CIII
Cypionate
Injection, USP
1,000 mg/10 mL
(100 mg/mL)
FOR INTRAMUSCULAR USE ONLY
Sterile. Protect from light.
Rx only 10 mL Multidose Vial
SANDOZ
NDC 0781-3073-70
CIII
Testosterone
Cypionate
Injection, USP
1,000 mg/10 mL
(100 mg/mL)
FOR INTRAMUSCULAR
USE ONLY
Sterile
Rx only
10 mL
Multidose Vial
SANDOZ
NDC 0781-3074-71
Testosterone CIII
Cypionate
Injection, USP
200 mg/mL
FOR IM USE ONLY. Sterile.
Rx only
1 mL Vial
Manufactured in Canada by
Sandoz Canada Inc. for
Sandoz Inc.,
Princeton, NJ 08540
NDC 0781-3074-71
CIII
Testosterone
Cypionate
Injection, USP
200 mg/mL
FOR INTRAMUSCULAR
USE ONLY
Sterile
Rx only
1 mL Vial
SANDOZ
NDC 0781-3074-70
Testosterone CIII
Cypionate
Injection, USP
2,000 mg/10 mL
(200 mg/mL)
FOR INTRAMUSCULAR USE ONLY
Sterile. Protect from light.
Rx only 10 mL Multidose Vial
SANDOZ
NDC 0781-3074-70
CIII
Testosterone
Cypionate
Injection, USP
2,000 mg/10 mL
(200 mg/mL)
FOR INTRAMUSCULAR
USE ONLY
Sterile
Rx only
10 mL
Multidose Vial
SANDOZ
| Testosterone CYPIONATE Testosterone cypionate injection, solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA040615 | 08/10/2006 | |
| Testosterone CYPIONATE Testosterone cypionate injection, solution | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA040615 | 08/10/2006 | |
| Labeler - Sandoz Inc (110342024) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sandoz Canada Inc | 244062071 | MANUFACTURE | |
Midazolam DeltaSelect may be available in the countries listed below.
Midazolam hydrochloride (a derivative of Midazolam) is reported as an ingredient of Midazolam DeltaSelect in the following countries:
International Drug Name Search
Gastirin may be available in the countries listed below.
Cimetidine is reported as an ingredient of Gastirin in the following countries:
International Drug Name Search
Azrogen may be available in the countries listed below.
Lorazepam is reported as an ingredient of Azrogen in the following countries:
International Drug Name Search
Glimepirida Teva may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimepirida Teva in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Roxarsone is reported as an ingredient of Pig Scour in the following countries:
International Drug Name Search
Hartil HCT may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Hartil HCT in the following countries:
Ramipril is reported as an ingredient of Hartil HCT in the following countries:
International Drug Name Search
Generic Name: butalbital and acetaminophen combination (Oral route)
In the U.S.
Available Dosage Forms:
Butalbital and acetaminophen combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
When you take butalbital for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.
Some butalbital and acetaminophen combinations also contain caffeine. Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.
Butalbital and acetaminophen combination may also be used for other kinds of headaches or other kinds of pain as determined by your doctor.
These medicines are available only with your doctor's prescription.
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
For butalbital:
For acetaminophen:
For caffeine:
For butalbital:
For acetaminophen:
For caffeine:
For butalbital:
For acetaminophen:
For caffeine:
For butalbital:
For acetaminophen:
For caffeine:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain butalbital and acetaminophen combination. It may not be specific to Fioricet. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital and acetaminophen combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and acetaminophen combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take these medicines to relieve frequent headaches. Taking too much of this medicine may also lead to liver damage or other medical problems.
This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.
People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.
The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Check with your doctor:
Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate or acetaminophen, check with your health care professional. Taking them together with this medicine may cause an overdose.
The butalbital in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking this medicine may increase the chance of liver damage, especially if you take more of this medicine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.
This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine (present in some butalbital and acetaminophen combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital and acetaminophen combinations.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital.
If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.
If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or possibly death. Signs of butalbital overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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