Pms-Alendronate-FC Uses

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Pms-Alendronate-FC indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Pms-Alendronate-FC 10 mg: Treatment of osteoporosis in postmenopausal women to prevent fractures; osteoporosis in men to prevent fractures; glucocorticoid-induced osteoporosis and prevention of bone loss in men and women considered at risk of developing the disease; prevention of osteoporosis in those postmenopausal women considered at risk of developing the disease.

Risk factors often associated with the development of osteoporosis include thin body build, family history of osteoporosis, early menopausal, moderately low bone mass and long-term glucocorticoid therapy, especially with high doses (15 mg/day).

Pms-Alendronate-FC 70 mg: Treatment of postmenopausal osteoporosis. Pms-Alendronate-FC reduces the risk of vertebral and hip fractures.

Uses of Pms-Alendronate-FC in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Prevention and treatment of post-menopausal osteoporosis in women.

Pms-Alendronate-FC may be used in some cancers and diseases to slow down the activity of osteoclasts, the cells that break down bone. Increased activity of these cells increases the levels of calcium in the blood. Paget’s disease of the bone.

Pms-Alendronate-FC description

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Pms-Alendronate-FC (alendronate) is a nitrogen-containing, second generation bisphosphonate. Bisphosphonates were first used to treat Paget’s disease in 1971. This class of medications is comprised of inorganic pyrophosphate analogues that contain non-hydrolyzable P-C-P bonds. Similar to other bisphosphonates, alendronate has a high affinity for bone mineral and is taken up during osteoclast resorption. Alendronate inhibits farnesyl pyrophosphate synthetase, one of the enzymes in the mevalonic acid pathway involved in producing isoprenoid compounds that are essential for post-translational modification of small guanosine triphosphate (GTP)-binding proteins, such as Rho, Ras and Rab. Inhibition of this process interferes with osteoclast function and survival. Alendronate is used for the treatment of osteoporosis and Paget’s disease.

Pms-Alendronate-FC dosage

Osteoporosis in Postmenopausal Women: Recommended Dose: 10 mg once a day or 70 mg once weekly.

Osteoporosis in Men: Recommended Dose: 10 mg once a day.

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: Postmenopausal Women Not Receiving Hormone Therapy Replacement (HRT) With An Oestrogen: Recommended Dose: 10 mg once a day.

Others (ie, Men, Premenopausal Women and Postmenopausal Women Receiving HRT With An Oestrogen): Recommended Dose: 5 mg once a day.

Prevention of Osteoporosis in Postmenopausal Women: Recommended Dose: 5 mg once a day.

Elderly: In clinical studies, there was no age-related difference in the efficacy or safety profiles of Pms-Alendronate-FC. Therefore, no dosage adjustment is necessary for the elderly.

Renal Impairment: No dosage adjustment is necessary for patients with glomerular filtration rate (GFR) >35 mL/min. Pms-Alendronate-FC is not recommended for patients with renal impairment where GFR is <35 mL/min, due to lack of experience.

Administration: To Permit Adequate Absorption of Pms-Alendronate-FC: Pms-Alendronate-FC must be be taken at least 30 min before the 1st food, beverage or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of Pms-Alendronate-FC.

To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences : Pms-Alendronate-FC should only be swallowed upon arising for the day with a full glass of water (not <200 mL or fl. oz.).

Patients should not chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.

Patients should not lie down for at least 30 min after taking Pms-Alendronate-FC.

Pms-Alendronate-FC should not be taken at bedtime or before arising for the day.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Pms-Alendronate-FC interactions

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If taken at the same time it is likely that calcium supplements, antacids and other oral medications will interfere with absorption of Pms-Alendronate-FC. Therefore, patients must wait at least ½ hr after taking Pms-Alendronate-FC before taking any other oral medication.

No other drug interaction of clinical significance are anticipated.

Concomitant use of HRT and alendronate sodium was assessed in 2 clinical studies of 1 or 2 years' duration in postmenopausal osteoporotic women. Combined use of alendronate sodium and HRT resulted in greater increases in bone mass, together with greater decreases in bone turnover, than seen with either treatment alone. In these studies, the safety and tolerability profile of the combination was consistent with those of the individual treatments.

In clinical studies, the incidence of upper GI adverse events was increased in patients receiving daily therapy with dosages of alendronate sodium >10 mg and aspirin-containing products. However, this was not observed in studies with alendronate sodium 70 mg once weekly.

Pms-Alendronate-FC side effects

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The following adverse experiences have been reported during clinical studies and/or post-marketing use: Common (1% and <10%): Gastrointestinal: Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distention, acid regurgitation.

Musculoskeletal: Musculoskeletal (bone, muscle or joint) pain.

Neurological: Headache.

Uncommon (0.1% and <1%): Body as a Whole: Rash, pruritus, erythema.

Gastrointestinal: Nausea, vomiting, gastritis, oesophagitis, oesophageal erosions, melaena.

Rare (0.01% and <0.1%): Body as a Whole: Hypersensitivity reactions including urticaria and angioedema. Transient symptoms as in acute-phase response (myalgia, malaise, and rarely, fever), typically in association with initiation of treatment. Rash with photosensitivity. Symptomatic hypocalcaemia, occasionally severe, often in association with predisposing conditions.

Gastrointestinal: Oesophageal stricture, oropharyngeal ulceration, upper gastrointestinal perforation, ulcers, bleeding (PUBs), although a casual relationship cannot be ruled out. Localised osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing.

Musculoskeletal: Severe musculoskeletal (bone, muscle or joint) pain.

Special Senses: Uveitis, scleritis, episcleritis.

Very Rare, Including Isolated Cases: Skin: Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Adverse experiences reported by the investigators as possibly, probably or definitely drug-related are presented as follows if they occured in 1% in either treatment group in the 1-year study, or in 1% patients treated with alendronate 10 mg/day and at a greater incidence than in patients given placebo in the 3-year studies.

Laboratory Test Findings: In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 and 10%, respectively, of patients taking alendronate versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8 mg/dL (2 mmol/L) and serum phosphate to 2 mg/dL (0.65 mmol/L) were similar in both treatment groups.

Pms-Alendronate-FC contraindications

Hypersensitivity to alendronate or to any of the excipients of Pms-Alendronate-FC.

Use in pregnancy: Pms-Alendronate-FC should not be used during pregnancy.

Use in lactation: It is not known whether Pms-Alendronate-FC is excreted into human breast milk. Pms-Alendronate-FC should not be used by breastfeeding women.

Active ingredient matches for Pms-Alendronate-FC:

Alendronic Acid


Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg
PMS-alendronate-FC tablet 70 mg (Pharmascience Inc (Canada))

List of Pms-Alendronate-FC substitutes (brand and generic names):

PMS-alendronate tablet 70 mg (Pharmascience Inc (Canada))
Poronil 10mg TAB / 10
10 mg x 10's
Ralenost 70 mg x 1 x 4's (Sun Pharma)
Ralenost tab 10 mg 10's (Sun Pharma)
Ralenost tab 70 mg 4's (Sun Pharma)
Ralenost-10 10mg TAB / 10 (Ranbaxy (Consumer HC))$ 0.79
10 mg x 10's (Ranbaxy (Consumer HC))$ 0.79
RALENOST-10 tab 10 mg x 10's (Ranbaxy (Consumer HC))$ 0.79
Ran-alendronate tablet 10 mg (Ranbaxy Pharmaceuticals Canada Inc. (Canada))
Ran-alendronate tablet 70 mg (Ranbaxy Pharmaceuticals Canada Inc. (Canada))
Ran-alendronate tablet 5 mg (Ranbaxy Pharmaceuticals Canada Inc. (Canada))
Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg
Reventa tab 70 mg 4's (Getz Pharma)$ 18.18
Tablet; Oral; Alendronic Acid / Alendronate Sodium Trihydrate 70 mg
1 g x 1's (Biomax)$ 33.33
Romax 1g INJ / 1 (Biomax)$ 33.33
Tablet; Oral; Alendronic Acid / Alendronate Sodium 10 mg
Tablet; Oral; Alendronic Acid / Alendronate Sodium 5 mg
Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg
Sandoz Alendronate tablet 40 mg (Sandoz Canada Incorporated (Canada))
Sandoz Alendronate tablet 10 mg (Sandoz Canada Incorporated (Canada))
Sandoz Alendronate tablet 70 mg (Sandoz Canada Incorporated (Canada))
Sandoz Alendronate tablet 5 mg (Sandoz Canada Incorporated (Canada))

References

  1. DailyMed. "ALENDRONATE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "ALENDRONIC ACID". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "ALENDRONIC ACID". http://www.drugbank.ca/drugs/DB00630 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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