Lipotalon tablets

Lipotalon

  • Active Ingredient: Dexamethasone
  • 1 mg, 0.5 mg
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What is Lipotalon?

The active ingredient of Lipotalon brand is dexamethasone. Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.

Used for

Lipotalon is used to treat diseases such as: Addison's Disease, Adrenal Insufficiency, Adrenocortical Insufficiency, Adrenogenital Syndrome, Allergic Rhinitis, Ankylosing Spondylitis, Aphthous Ulcer, Aspiration Pneumonia, Asthma, Asthma, acute, Atopic Dermatitis, Bronchopulmonary Dysplasia, Bursitis, Cerebral Edema, Chorioretinitis, Croup, Cushing's Syndrome, Dermatitis Herpetiformis, Eczema, Epicondylitis, Tennis Elbow, Erythroblastopenia, Evan's Syndrome, Gouty Arthritis, Hemolytic Anemia, Hypercalcemia of Malignancy, Idiopathic Thrombocytopenic Purpura, Inflammatory Bowel Disease, Inflammatory Conditions, Iridocyclitis, Iritis, Juvenile Rheumatoid Arthritis, Keratitis, Leukemia, Loeffler's Syndrome, Lymphoma, Meningitis, Haemophilus influenzae, Meningitis, Listeriosis, Meningitis, Meningococcal, Meningitis, Pneumococcal, Mountain Sickness / Altitude Sickness, Multiple Myeloma, Multiple Sclerosis, Mycosis Fungoides, Nausea/Vomiting, Chemotherapy Induced, Neurosarcoidosis, Pemphigus, Plaque Psoriasis, Psoriasis, Psoriatic Arthritis, Pulmonary Tuberculosis, Rheumatoid Arthritis, Sarcoidosis, Seborrheic Dermatitis, Shock, Synovitis, Systemic Lupus Erythematosus, Thrombocytopenia, Toxic Epidermal Necrolysis, Transverse Myelitis, Tuberculous Meningitis, Ulcerative Colitis, Uveitis, Posterior.

Side Effect

Possible side effects of Lipotalon include: Aggression; anxiety; dizziness; nervousness; fruit-like breath odor; blurred vision; shortness of breath; increased urination.

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Before receiving Lipotalon injection,

  • tell your doctor and pharmacist if you are allergic to Lipotalon, any other medications, benzyl alcohol, or any of the ingredients in Lipotalon injection. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amphotericin B (Abelcet, Ambisome, Amphotec); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) and selective COX-2 inhibitors such as celecoxib (Celebrex); medications for diabetes including insulin; diuretics ('water pills'); ephedrine; phenobarbital; phenytoin (Dilantin, Phenytek); and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have a fungal infection (other than on your skin or nails). Your doctor will probably tell you not to use Lipotalon injection.
  • tell your doctor if you have or have ever had tuberculosis (TB: a type of lung infection); cataracts (clouding of the lens of the eye); glaucoma (an eye disease); high blood pressure; a recent heart attack; emotional problems, depression or other types of mental illness; myasthenia gravis (a condition in which the muscles become weak); osteoporosis (condition in which the bones become weak and fragile and can break easily); malaria (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death); ulcers; or liver, kidney, heart, intestinal, or thyroid disease. Also tell your doctor if you have any type of untreated bacterial, parasitic, or viral infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface).
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving Lipotalon injection, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving Lipotalon injection.
  • do not have any vaccinations (shots to prevent diseases) without talking to your doctor.
  • you should know that Lipotalon injection may decrease your ability to fight infection and may prevent you from developing symptoms if you get an infection. Stay away from people who are sick and wash your hands often while you are using this medication. Be sure to avoid people who have chicken pox or measles. Call your doctor immediately if you think you may have been around someone who had chicken pox or measles.

Lipotalon injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • slowed healing of cuts and bruises
  • thin, fragile, or dry skin
  • red or purple blotches or lines under the skin
  • skin depressions at the injection site
  • increased body fat or movement to different areas of your body
  • inappropriate happiness
  • difficulty falling asleep or staying asleep
  • extreme changes in mood changes in personality
  • depression
  • increased sweating
  • muscle weakness
  • joint pain
  • irregular or absent menstrual periods
  • hiccups
  • increased appetite
  • injection site pain or redness

Before taking this medicine

You should not use Lipotalon if you are allergic to it, or if you have:

Lipotalon Warnings

Your doctor will not prescribe Lipotalon if you have a fungal infection anywhere in your body since the medicine may worsen the infection.

If you are allergic to Lipotalon, you need to alert your doctor.

While taking this medicine, do not get any vaccines without your doctor's permission. The medicine may affect the way the vaccine works.

If someone in your household has had a live virus vaccine (measles, mumps, nasal flu vaccine), you should avoid contact with them while taking Decadron. Ask your doctor for details.

Cholesterol drugs

If you take Lipotalon with certain drugs used to lower cholesterol, it can keep your body from absorbing Lipotalon well. This could keep Lipotalon from working well. Examples of these drugs include:

  • cholestyramine
  • colesevelam
  • colestipol

How should this medicine be used?

Lipotalon injection comes as powder to be mixed with liquid to be injected intramuscularly (into a muscle) or intravenously (into a vein). Your personal dosing schedule will depend on your condition and on how you respond to treatment.

You may receive Lipotalon injection in a hospital or medical facility, or you may be given the medication to use at home. If you will be using Lipotalon injection at home, your healthcare provider will show you how to inject the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems using Lipotalon injection.

Your doctor may change your dose of Lipotalon injection during your treatment to be sure that you are always using the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, or infection. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment.

Getting the most from your treatment

  • If your course of treatment is due to last more than three weeks, you will be given a 'Steroid Treatment Card' which says that you are on steroids and contains some important advice for you. It is important that you read this card and carry it with you at all times. It also contains details about your dose, how long you have been taking Lipotalon for, and who prescribed it for you. Please make sure that this information is kept up to date. If you are having an operation or dental treatment or any treatment for an injury, tell the person carrying out the treatment that you are taking Lipotalon and show them your treatment card. This is because your dose may need adjusting.
  • Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. Your doctor will want you to have tests from time to time to make sure you remain free from some of the unwanted side-effects of treatment.
  • Lipotalon can suppress your immune system, so it is important if you become ill that you make an appointment to see your doctor straightaway. Also, if you come into contact with anyone who has measles, shingles or chickenpox (or anyone who suspects they might have them), you must see your doctor as soon as possible.
  • Some vaccines are not suitable for you while you are being treated with Lipotalon. If you need any immunisations, make sure you mention that you are taking an oral steroid.
  • If you buy any medicines, check with your pharmacist that they are suitable to take with Lipotalon.

HOW SUPPLIED

Lipotalon Tablets USP:

0.5 mg yellow, scored tablets (Identified 54 299).

NDC 0054-8179-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4179-25: Bottles of 100 tablets.

0.75 mg pale blue, scored tablet (Identified 54 960).

NDC 0054-8180-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4180-25: Bottles of 100 tablets.

1 mg yellow, scored tablets (Identified 54 489).

NDC 0054-8174-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4181-25: Bottles of 100 tablets.

1.5 mg pink, scored tablets (Identified 54 943).

NDC 0054-8181-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4182-25: Bottles of 100 tablets. NDC 0054-4182-31: Bottles of 1000 tablets.

2 mg white, scored tablets (Identified 54 662).

NDC 0054-8176-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4183-25Bottles of 100 tablets.

4 mg green, scored tablets (Identified 54 892).

NDC 0054-8175-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4184-25: Bottles of 100 tablets.

6 mg aqua, scored tablets (Identified 54 769).

NDC 0054-8183-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. NDC 0054-4186-25:Bottles of 100 tablets.

Store and Dispense

Store at 20° to 25°C (68° to 77°F) . Protect from moisture. Dispense in a well-closed, light-resistant container as defined in the USP/NF.

Lipotalon Oral Solution, 0.5 mg per 5 mL:

NDC 0054-3177-57: Bottles of 240 mL. NDC 0054-3177-63: Bottles of 500 mL.

Store and Dispense

Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP/NF.

Lipotalon Intensol ™ Oral Solution (Con-centrate), 1 mg per mL:

NDC 0054-3176-44: Bottles of 30 mL with calibrated dropper .

Store and Dispense

Store at 20° to 25°C (68° to 77°F) . Do not freeze. Do not use if solution contains a precipitate. Dispense only in this bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.

Boehringer Ingelheim, Roxane laboratories. Revised September 2007. FDA revision date: 08/28/96

Lipotalon belongs to a group of medicines called corticosteroids. It is sometimes referred to simply as an oral steroid. Corticosteroids are produced naturally in your body. They help to keep you healthy. By boosting your body with extra corticosteroid, it can help treat conditions involving inflammation.

More common side effects

The more common side effects that can occur with Lipotalon oral tablets include:

  • nausea
  • vomiting
  • stomach upset
  • swelling (edema)
  • headache
  • dizziness
  • mood changes, such as depression, mood swings, or personality changes
  • trouble falling asleep
  • anxiety
  • low potassium levels (causing symptoms such as tiredness)
  • high blood glucose
  • high blood pressure

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Corticostero > Lipotalon is a synthetic glucocorticoid with antiinflammatory and immunosuppressant properties. With 20 to 30 times the binding affinity for glucocorticoid receptors of endogenous cortisol, Lipotalon is a potent treatment for PONV and CINV. Even though Lipotalon is one of the most commonly used antiemetics, its mechanism of action remains unclear. Studies in animal models suggest that Lipotalon acts on the glucocorticoid receptor-rich bilateral nucleus tractus solitarius (i.e., the vomiting center), but not the area postrema. 33

Although 8 mg is the most commonly used dose for prevention of PONV, dose-response studies suggest that 5 mg is the minimum effective dose for PONV prophylaxis ( Figure 29-6 ). 34 Furthermore, a large factorial trial in more than 5000 patients found that 4 mg Lipotalon has similar efficacy to 4 mg ondansetron or 1.25 mg droperidol. 35 Thus ambulatory surgery guidelines recommend 4 to 5 mg Lipotalon. 36 Lipotalon is more effective when given at the beginning rather at the end of surgery, which suggests that there is a delay in onset of action by about 2 hours. 37 Furthermore, a single intraoperative dose of Lipotalon has not been associated with adverse effects. 36 However, like other intravenous drugs containing phosphate esters, Lipotalon has been associated with perineal burning and itching when injected in awake patients. 38 In addition, doses of 12 to 20 mg can be given for CINV. 39


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