Generic Risedronate Tablets

Generic Risedronate Sodium tablets (Gemfos) - Product Information

Generic Risedronate Sodium tablets (Gemfos) belongs to the group of medicines called bisphosphonate and is used for treatment and prevention of postmenopausal osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis and treatment of Paget’s disease.

Gemfos tablets are manufactured by Alkem Laboratories Ltd., India in the strengths of 150 mg. We also have in stock Generic Boniva (Ibandronate Sodium 150 mg tablets) which is used for the treatment and prevention of osteoporosis in postmenopausal women.

Name of the Drug

We supply original Gemfos tablets manufactured by Alkem Laboratories, India.

Manufacturer of Gemfos Tablets

Alkem Laboratories Ltd. 
Website: www.alkemlabs.com

Active Ingredient present in Gemfos Tablets

The active ingredient present in Gemfos tablets is Risedronate Sodium. Each Gemfos tablet contains 150 mg of Risedronate.

Uses of Gemfos Tablets

Gemfos tablets (Generic Risedronate Sodium) works directly on your bones to make them stronger and therefore less likely to break or fracture, by slowing down the process of old bone being removed and helping in the process of rebuilding the bone mass.
Gemfos tablets are used to treat the following bone diseases:
Gemfos is used for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Gemfos reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fracture.
Gemfos is used for treatment to increase bone mass in men with osteoporosis.
Gemfos is used for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of 7.5 mg Prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
Gemfos tablets (Generic Risedronate Sodium) is also used for treatment of Paget's disease of bone in men and women.

Risedronate Sodium Mechanism of Action

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronate Sodium inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that treatment with Risedronate Sodium tablets reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites

Gemfos tablets (Generic Risedronate Sodium) - Dosage

The recommended dosage of Gemfos tablets (Generic Risedronate Sodium) for various indications is given below.
Treatment of Postmenopausal Osteoporosis:
The recommended dosage is one 5 mg tablet orally, taken daily or one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month or one 150 mg tablet orally, taken once-a-month.

Prevention of Postmenopausal Osteoporosis:
The recommended dosage is one 5 mg tablet orally, taken daily or alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered or alternatively, one 150 mg tablet orally, taken once-a-month may be considered.

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis:
The recommended dosage is one 5 mg tablet orally, taken daily.

Treatment of Paget's Disease:
The recommended dosage for treatment of this indication is 30 mg orally once daily for 2 months. Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For retreatment, the dose and duration of therapy are the same as for initial treatment. No data are available on more than 1 course of retreatment.

How To Take Gemfos Tablets

Instruct patients must take Risedronate Sodium tablets (Gemfos) at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit. Patients should avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium.

Risedronate Sodium tablets must be swallowed whole with a full glass of plain water (6 to 8 ounces). Patient smust be told that they must avoid lying down for 30 minutes after taking the medicine. The tablet should not be chewed or sucked because of a potential for oropharyngeal ulceration.

Patients must not eat or drink anything except plain water, or take other medications for at least 30 minutes after taking risedronate sodium tablets.

Gemfos tablets (Generic Risedronate Sodium) Storage

Store Gemfos tablets (Generic Risedronate Sodium) at controlled room temperature (59°F to 86°F, 15°C to 30°C). Protect from light.

Gemfos Tablets Contraindications

Gemfos tablets tablets are contraindicated in patients with a hypersensitivity to Risedronate Sodium or any inactive ingredient present in tablets. Gemfos tablets are contraindicated in the following cases: Hypocalcaemia or inability to stand or sit upright for at least 30 minutes.
Other contraindications include Pregnancy and lactation and severe renal impairment (creatinine clearance less than 30ml/min).

Warnings and Precautions

Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should not be taken at the same time as risedronate sodium in order to achieve the intended efficacy.
Efficacy of bisphosphonates in the treatment of osteoporosis is related to the presence of low bone mineral density and/or prevalent fracture.
High age or clinical risk factors for fracture alone are not sufficient reasons to initiate treatment of osteoporosis with a bisphosphonate.
The evidence to support efficacy of bisphosphonates including Risedronate Sodium in very elderly (greater than 80 years) is limited
Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations. Thus, caution should be used:

• In patients who have a history of oesophageal disorders which delay oesophageal transit or emptying e.g. stricture or achalasia
• In patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet.
• If Risedronate Sodium is given to patients with active or recent oesophageal or upper gastrointestinal problems (including known Barrett's oesophagus).

Doctors must emphasise to patients the importance of paying attention to the dosing instructions and be alert to any signs and symptoms of possible oesophageal reaction. The patients should be told to seek timely medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn.
Hypocalcaemia should be treated before starting Risedronate Sodium therapy. Other disturbances of bone and mineral metabolism (e.g. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting risedronate sodium therapy.
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. Stopping treatment with bisphosphonate in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphophonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects On Ability To Drive And Use Machines

The effects of Risedronate Sodium (Gemfos tablets) on a person's ability to drive and use machines were not assessed.However, side effects of this medicine include dizziness, which could affect the ability to drive or use machines.

Risedronate Sodium (Gemfos tablets) Side Effects

Most common side effects reported in more than 10% of patients treated with Risedronate Sodium (Gemfos tablets) and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia.
Risedronate side effects occurring in 5% or more of patients of either treatment group in the daily versus once a week osteoporosis treatment study in postmenopausal women included Infection, Accidental injury, Pain, Back pain, Flu syndrome, Abdominal pain, Headache, Overdose, Asthenia, Hypertension, Constipation, Dyspepsia, Nausea, Diarrhoea, Arthralgia, Traumatic bone fracture, Myalgia and Dizziness

Risedronate Sodium Tablets Overdosage

Decreases in serum calcium and phosphorus following substantial overdose of Risedronate Sodium (Gemfos tablets) may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind Risedronate and reduce absorption of the medicine.

In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed medication. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia.

Risedronate Sodium During Pregnancy

Risedronate Sodium (Gemfos tablets) has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies of Risedronate Sodium tablets in pregnant women. Risedronate should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

The amount of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, mainly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Do not use this medicine without your doctor's consent in case you are pregnant. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.

Risedronate Sodium (Gemfos tablets) Nursing Considerations

Risedronate Sodium (Gemfos tablets) was detected in feeding pups exposed to lactating rats for a 24-hour period post-dosing, indicating a small degree of lacteal transfer. It is not known whether Risedronate is excreted in human milk.

Since many medicines are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Risedronate, a decision should be made whether to discontinue nursing or to discontinue the medication, taking into account the importance of the drug to the mother.
Do not use this medication without telling your doctor if you are breast-feeding a baby.

Buy Generic Risedronate Sodium (Gemfos Tablets) Pills Online at Only $4.30 per Pill

You can buy Generic Risedronate Sodium tablets online from Clear Sky Pharmacy at a cheap price. Gemfos 150 mg pills, manufactured by Alkem Laboratories, India are supplied in a blister strip of 4 tablets. The 150 mg tablets cost only $4.30 per unit when you place an order for 60 tablets.

Disclaimer

The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.

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