Actimax

Actimax

  • Active Ingredient: Alendronate
  • 70 mg, 35 mg, 5 mg
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What is Actimax?

The active ingredient of Actimax brand is alendronate. Alendronate is a bisphosphonate (bis FOS fo nayt) medicine that slows bone loss while increasing bone mass, which may prevent bone fractures. Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Alendronate sodium tablets, USP, for oral administration contain 45.68 mg or 91.37 mg of Alendronate monosodium salt trihydrate, which is the molar equivalent of 35 mg and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. This product meets USP Dissolution Test 2.

Used for

Actimax is used to treat diseases such as: Aseptic Necrosis, Osteoporosis, Paget's Disease, Prevention of Osteoporosis.

Side Effect

Possible side effects of Actimax include: chest pain; unusual weight gain or loss; Abdominal or stomach cramps; red skin lesions, often with a purple center; cough; red, irritated eyes; redness of the skin.

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Who should take Actimax?

Actimax is usually prescribed for postmenopausal women, men and occasionally younger women.

Actimax doesn't suit everyone. It may not be the best treatment for you if:

  • you have Barrett’s oesophagus
  • you have severe kidney problems
  • you are pregnant or breast feeding
  • you have difficulty swallowing tablets

Side Effects

Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: jaw/ear pain, increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, swelling of joints/hands/ankles/feet, black/tarry stools, vomit that looks like coffee grounds.

This medication may rarely cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking Actimax and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Q: Is it safe to take Fosamax over a long period of time? What are the side effects?

A: Fosamax (Actimax) is in a drug class called bisphosphonates. Fosamax is used to prevent and treat osteoporosis (thinning and weakening of bones which may cause them to break easily) in women who have been through menopause. Fosamax is also used to treat osteoporosis in men. Additionally, Fosamax is used to treat osteoporosis in women and men who are taking corticosteroids, which are medicines that have the potential to cause osteoporosis. Also, Fosamax is used to treat Paget's disease of bone, which is a disorder where bones are soft, weak, and may be deformed, cause pain, and break easily. Fosamax works by preventing the breakdown of bone and increasing bone density (thickness of bone). Fosamax should be taken with a glass of water and no other food or drink should be consumed for 30 minutes. Also, do not lie down after taking Fosamax, it is important to remain up straight for at least 30 minutes after taking Fosamax. According to National Osteoporosis Foundation (NOF), Fosamax lessens bone loss and increases bone density. In addition, according to NOF, Fosamax reduces the risk of spine, hip and other fractures by approximately 50% over 2 to 4 years. Some of the common side effects experienced with Fosamax include: abdominal pain, nausea, acid reflux, gas, constipation and headache. Severe bone/joint/muscle pain has been reported with the use of Fosamax. Some people experienced this pain within 1 day to several months after starting Fosamax. The pain usually subsides with discontinuation of the medication. Some people will have the pain reoccur if they are rechallenged with Fosamax or another bisphosphonate. One of the rare side effects of Fosamax is called osteonecrosis of the jaw (ONJ). ONJ may occur spontaneously after dental procedures or tooth extractions. There may be delayed healing after dental procedures and the bone of the jaw becomes exposed. Symptoms of ONJ may include: pain, swelling, infection, poor healing, loosening of teeth, or numbness of the jaw. According to the National Osteoporosis Foundation, it is important for patients taking Fosamax, or similar medications, to maintain good oral hygiene and have regular dental visits. Fosamax may also cause problems with the esophagus. The esophagus is the tube that connects the mouth to the stomach. Fosamax can cause irritation and erosion to the esophagus, especially if the dosing directions are not followed. Low blood calcium (hypocalcemia) has been reported with the use of Fosamax. Before therapy is started, calcium levels should be checked and it is important for the patient to have adequate calcium and vitamin D supplementation during therapy. This is not a complete list of the side effects associated with Fosamax. Please consult with your doctor about the long term use of Fosamax and the duration of treatment appropriate for you. For more specific information, consult with your doctor for guidance based on your health status and current medications, particularly before taking any action. Kristen Dore, PharmD

Monitoring

Baseline levels of calcium and bone mineral density should be established before therapy begins, with follow-up testing at 6 to 12 months post-therapy. Calcium at baseline and continual monitoring is needed if hypocalcemia risk is recurring. The clinician should decrease the dose or discontinue therapy if hypocalcemia occurs during treatment. Magnesium and phosphorus require monitoring at regular intervals.

The physician should offer some form of a drug-holiday to patients on Actimax therapy. The accumulation of Actimax in the kidney allows for persistent anti-fracture benefits even after cessation of therapy. Current recommendations suggest tailoring the drug holiday length to the individual patients. The average drug-holiday in low-risk patients is 3 to 5 years. It also bears mention that Actimax is an extremely safe drug, and the benefits of continued therapy often outweigh the benefits of a drug holiday.

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

  • nausea
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • bloating or fullness in the stomach
  • change in ability to taste food
  • headache
  • dizziness
  • swelling of the joints, hands, or legs

Osteonecrosis of the Jaw

​ Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Actimax sodium. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.

For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.

Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.

Overdosage

Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m 2 ) and 966 mg/kg (2898 mg/m 2 ), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m 2 ).

No specific information is available on the treatment of overdosage with Actimax sodium. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind Actimax. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.

Dialysis would not be beneficial.

What do I need to tell my doctor BEFORE I take Actimax Tablets?

  • If you have an allergy to Actimax or any other part of this medicine (Actimax tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: A swallowing tube (esophagus) that is not normal, low calcium levels, kidney disease, or trouble swallowing.
  • If you are not able to stand or sit up for 30 minutes.

This is not a list of all drugs or health problems that interact with this medicine (Actimax tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Actimax tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What special dietary instructions should I follow?

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking Actimax. Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

Dictionary Entries near Actimax

Cite this Entry

“Actimax.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Actimax. Accessed 27 December 2019.

Comments on Actimax

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How should this medicine be used?

Actimax comes as a tablet and a solution (liquid) to take by mouth. The solution is usually taken on an empty stomach once a week in the morning. The 5-mg and 10-mg tablets are usually taken on an empty stomach once a day in the morning, and the 35-mg and 70-mg tablets are usually taken on an empty stomach once a week in the morning. The 40-mg tablets are usually taken once a day in the morning for six months to treat Paget's disease of bone. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Actimax exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Q: A friend told me there was an osteoporosis study that said that if you take Fosamax for more than 5 years, it will do more harm than good. Are you aware of this study and is it true?

A: A recent ABC News report did raise questions about whether there is an increased risk of spontaneous femur fractures in patients with osteoporosis who have been on Fosamax (Actimax) for more than5years. While the Food and Drug Administration is reviewing the claims from the news report and conducting further investigations, at this point the FDA states that the data they have reviewed have not shown a clear connection between the class of drugs that Fosamax is in and a risk of these femur fractures. Until the FDA

Prevention of Osteoporosis in Postmenopausal Women Daily Dosing The safety of Actimax 5 mg/day in postmenopausal women 40 to 60 years of age has been evaluated in three double-blind, placebo-controlled studies involving over 1,400 patients randomized to receive Actimax sodium for either two or three years. In these studies the overall safety profiles of Actimax 5 mg/day and placebo were similar. Discontinuation of therapy due to any clinical adverse event occurred in 7.5% of 642 patients treated with Actimax 5 mg/day and 5.7% of 648 patients treated with placebo.

Weekly Dosing The safety of Actimax 35 mg once weekly compared to Actimax 5 mg daily was evaluated in a one-year, double-blind, multicenter study of 723 patients. The overall safety and tolerability profiles of once weekly Actimax 35 mg and Actimax 5 mg daily were similar.

The adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either once weekly Actimax 35 mg, Actimax 5 mg/day or placebo are presented in Table 3.

Q: I have osteopenia. Do I have to take Fosamax?

A: Fosamax (Actimax) is in a class of medications called bisphosphonates that work by increasing bone formation and decreasing bone breakdown in the body. If you have osteopenia, then you have a high risk of developing osteoporosis and possibly having a bone fracture in the future. You should consult your physician about osteoporosis prevention. The most common side effects of Fosamax are mild heartburn, diarrhea, gas, constipation, swelling in your hands or feet, dizziness, weakness, and headache. Contact your physician if any of the following severe side effects occur: chest pain, difficulty swallowing, new or worsening heartburn, joint/muscle or bone pain, jaw pain. This is not a complete list of side effects of Fosamax. Fosamax can cause problems in the stomach or esophagus. Staying upright for at least 30 minutes after taking this medication and taking it with a full glass of water can lower the risk of stomach problems. Always take Fosamax first thing in the morning 30 minutes before you eat or drink anything or take any other medications. Burton Dunaway, PharmD

How is this medicine (Actimax Tablets) best taken?

Use this medicine (Actimax tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take on an empty stomach before breakfast.
  • Take at least 30 minutes before the first food, drink, or drugs of the day.
  • Do not lie down for at least 30 minutes after taking this medicine (Actimax tablets).
  • Keep taking this medicine (Actimax tablets) as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • Take with a full glass of water.
  • Take with plain water only. Avoid taking with mineral water, milk, or other drinks.
  • Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

  • Do not take it later in the day.
  • Take the missed dose on the next morning after you think about it and then go back to your normal time.
  • Do not take 2 doses on the same day.

Treatment of Paget's Disease of Bone

Actimax sodium tablets are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.


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