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FOSAMAX® 10 mg Tablets
Each tablet contains 13.05 mg of alendronate sodium, which is the molar equivalent to 10 mg of alendronic acid.
Excipients:
Each tablet contains 103.95 mg lactose anhydrous.
For a full list of excipients see section 6.1
Tablets
Oval white tablets marked with '936' on one side, and plain on the other.
'Fosamax' is indicated for the treatment of osteoporosis in post-menopausal women to prevent fractures.
'Fosamax' is indicated for the treatment of osteoporosis in men to prevent fractures.
'Fosamax' is indicated for the treatment of glucocorticoid-induced osteoporosis and prevention of bone loss in post-menopausal 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 menopause, moderately low bone mass and long-term glucocorticoid therapy, especially with high doses (
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of ‘Fosamax’ on an individual patient basis, particularly after 5 or more years of use.
Treatment of osteoporosis in post-menopausal women: The recommended dosage is 10 mg once a day.
Treatment of osteoporosis in men: The recommended dosage is 10 mg once a day.
Treatment and prevention of glucocorticoid-induced osteoporosis: For post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen, the recommended dosage is 10 mg once a day.
To permit adequate absorption of 'Fosamax':
'Fosamax' must be taken at least 30 minutes before the first 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 'Fosamax' (see 4.5 'Interaction with other medicinal products and other forms of interaction').
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see 4.4 'Special warnings and precautions for use'):
• 'Fosamax' should only be swallowed upon arising for the day with a full glass of water (not less than 200 mls or 7 fl.oz.).
• Patients should only swallow 'Fosamax' whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
• Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
• Patients should not lie down for at least 30 minutes after taking 'Fosamax'.
• 'Fosamax' 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 (see 4.4 'Special warnings and precautions for use').
Use in the elderly: In clinical studies there was no age-related difference in the efficacy or safety profiles of 'Fosamax'. Therefore no dosage adjustment is necessary for the elderly.
Use in renal impairment: No dosage adjustment is necessary for patients with GFR greater than 35 ml/min. 'Fosamax' is not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to lack of experience.
Use in children (under 18 years): Alendronate has been studied in a small number of patients with osteogenesis imperfecta under 18 years of age. Results are insufficient to support its use in children.
• Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
• Inability to stand or sit upright for at least 30 minutes.
• Hypersensitivity to any component of this product.
• Hypocalcaemia (see 4.4 'Special warnings and precautions for use').
'Fosamax' can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when 'Fosamax' is given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis or ulcers or with a recent history (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastro-intestinal tract other than pyloroplasty (see 4.3 'Contraindications'). In patients with known Barrett's oesophagus prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture or perforation, have been reported in patients receiving 'Fosamax'. Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue 'Fosamax' and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain, new or worsening heartburn.
The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take 'Fosamax' properly and/or who continue to take 'Fosamax' after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to, and understood by the patient (see 4.2 'Posology and method of administration'). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
While no increased risk was observed in extensive clinical trials, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications.
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 bisphosphonates. 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.
The following risk factors should be considered when evaluating an individual's risk of developing osteonecrosis of the jaw:
• potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose
• cancer, chemotherapy, radiotherapy, corticosteroids, smoking
• a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with poor dental status.
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. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain or swelling.
Atypical fractures of the femur
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique, fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures are often bilaterial; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bishphosphonate therapy 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 bishphosphonate 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.
Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating (see '4.8 Undesirable effects'). The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
'Fosamax' is not recommended for patients with renal impairment where GFR is less than 35 ml/min, (see 4.2 'Posology and method of administration').
Causes of osteoporosis other than oestrogen deficiency, ageing and glucocorticoid use should be considered.
Hypocalcaemia must be corrected before initiating therapy with alendronate (see 4.3 'Contra-indications'). Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with 'Fosamax'.
Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased. These are usually small and asymptomatic. However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption). Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids.
Excipients
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product
If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of 'Fosamax'. Therefore, patients must wait at least 30 minutes after taking 'Fosamax' before taking any other oral medicinal product (see 4.2 'Posology and method of administration' and 5.2 'Pharmacokinetic properties')...
No other drug interactions of clinical significance are anticipated. Concomitant use of HRT (oestrogen ± progestin) and 'Fosamax' was assessed in two clinical studies of one or two years duration in post-menopausal osteoporotic women (5.1 'Pharmacodynamic properties, concomitant use with oestrogen/hormone replacement therapy (HRT)'). Combined use of 'Fosamax' 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.
Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Although specific interaction studies were not performed, in clinical studies 'Fosamax' was used concomitantly with a wide range of commonly prescribed drugs without evidence of clinical adverse interactions (see 5.1 'Pharmacodynamic properties' 'Concomitant use with oestrogen/hormone replacement therapy (HRT)').
Use during pregnancy
Alendronate should not be used during pregnancy. There are no adequate data from the use of alendronate in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/fetal development, or postnatal development. Alendronate given during pregnancy in rats caused dystocia related to hypocalcemia (see 5.3 'Preclinical safety data').
Use during lactation
It is not known whether alendronate is excreted into human breast-milk. Alendronate should not be used by breast-feeding women.
No studies on the effects on the ability to drive and use machines has been performed. However, certain adverse reactions that have been reported with 'Fosamax' may affect some patients' ability to drive or operate machinery. Individual responses to 'Fosamax' may vary (see section 4.8).
'Fosamax' has been studied in nine major clinical studies (n=5,886). In the longest running trials in post-menopausal women up to five years experience has been collected. Two years safety data are available in both men with osteoporosis and men and women on glucocorticoids.
The following adverse experiences have been reported during clinical studies and/or post-marketing use:
[Common ()]
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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 'Fosamax' versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8.0 mg/dl (2.0 mmol/l) and serum phosphate to
No specific information is available on the treatment of overdosage with 'Fosamax'. Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
'Fosamax' is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. The bone formed during treatment with 'Fosamax' is of normal quality.
Treatment of post-menopausal osteoporosis
The effects of 'Fosamax' on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459).
In the initial efficacy studies, the mean bone mineral density (BMD) increases with 'Fosamax' 10 mg/day relative to placebo at three years were 8.8%, 5.9% and 7.8% at the spine, femoral neck and trochanter, respectively. Total body BMD also increased significantly. There was a 48% reduction in the proportion of patients treated with 'Fosamax' experiencing one or more vertebral fractures relative to those treated with placebo. In the two-year extension of these studies BMD at the spine and trochanter continued to increase and BMD at the femoral neck and total body were maintained.
FIT consisted of two placebo-controlled studies: a three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture and a four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture, 37% of whom had osteoporosis as defined by a baseline femoral neck BMD at least 2.5 standard deviations below the mean for young, adult women. In all FIT patients with osteoporosis from both studies, 'Fosamax' reduced the incidence of:
Overall these results demonstrate the consistent effect of 'Fosamax' to reduce the incidence of fractures, including those of the spine and hip, which are the sites of osteoporotic fracture associated with the greatest morbidity.
Prevention of post-menopausal osteoporosis
The effects of 'Fosamax' to prevent bone loss were examined in two studies of post-menopausal women aged
Concomitant use with oestrogen/hormone replacement therapy (HRT)
The effects on BMD of treatment with 'Fosamax' 10 mg once-daily and conjugated oestrogen (0.625 mg/day) either alone or in combination were assessed in a two-year study of hysterectomised, post-menopausal, osteoporotic women. At two years, the increases in lumbar spine BMD from baseline were significantly greater with the combination (8.3%) than with either oestrogen or 'Fosamax' alone (both 6.0%).
The effects on BMD when 'Fosamax' was added to stable doses (for at least one year) of HRT (oestrogen ± progestin) were assessed in a one-year study in post-menopausal, osteoporotic women. The addition of 'Fosamax' 10 mg once-daily to HRT produced, at one year, significantly greater increases in lumbar spine BMD (3.7%) vs. HRT alone (1.1%).
In these studies, significant increases or favourable trends in BMD for combined therapy compared with HRT alone were seen at the total hip, femoral neck and trochanter. No significant effect was seen for total body BMD.
Treatment of osteoporosis in men
The efficacy of 'Fosamax' 10 mg once daily in men (ages 31 to 87; mean, 63) with osteoporosis was demonstrated in a two-year study. At two years, the mean increases relative to placebo in BMD in men receiving 'Fosamax' 10 mg/day were: lumbar spine, 5.3%; femoral neck, 2.6%; trochanter, 3.1%; and total body, 1.6%. 'Fosamax' was effective regardless of age, race, gonadal function, baseline rate of bone turnover, or baseline BMD. Consistent with much larger studies in post-menopausal women, in these 127 men, 'Fosamax' 10 mg/day reduced the incidence of new vertebral fracture (assessed by quantitative radiography) relative to placebo (0.8% vs. 7.1%) and, correspondingly, also reduced height loss (-0.6 vs. -2.4 mm).
Glucocorticoid-induced osteoporosis
The efficacy of 'Fosamax' 5 and 10 mg once-daily in men and women receiving at least 7.5 mg/day of prednisone (or equivalent) was demonstrated in two studies. At two years of treatment, spine BMD increased by 3.7% and 5.0% (relative to placebo) with 'Fosamax' 5 and 10 mg/day respectively. Significant increases in BMD were also observed at the femoral neck, trochanter, and total body. In post-menopausal women not receiving oestrogen, greater increases in lumbar spine and trochanter BMD were seen in those receiving 10 mg 'Fosamax' than those receiving 5 mg. 'Fosamax' was effective regardless of dose or duration of glucocorticoid use. Data pooled from three dosage groups (5 or 10 mg for two years or 2.5 mg for one year followed by 10 mg for one year) showed a significant reduction in the incidence of patients with a new vertebral fracture at two years ('Fosamax' 0.7% vs. placebo 6.8%).
Absorption
Relative to an intravenous (IV) reference dose, the oral bioavailability of alendronate in women was 0.7% for doses ranging from 5 to 40 mg when administered after an overnight fast and two hours before a standardised breakfast. Oral bioavailability in men (0.6%) was similar to that in women. Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardised breakfast. In osteoporosis studies, 'Fosamax' was effective when administered at least 30 minutes before the first food or beverage of the day.
Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20% to 44%).
Distribution
Studies in rats show that alendronate transiently distributes to soft tissues following 1 mg/kg IV administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans. Concentrations of drug in plasma following therapeutic oral doses are too low for analytical detection (<5 ng/ml). Protein binding in human plasma is approximately 78%.
Biotransformation
There is no evidence that alendronate is metabolised in animals or humans.
Elimination
Following a single IV dose of [14C] alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces. Following a single 10 mg IV dose, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min. Plasma concentrations fell by more than 95% within six hours following IV administration. The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton. Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not anticipated to interfere with the excretion of other drugs by those systems in humans.
Characteristics in patients
Preclinical studies show that the drug that is not deposited in bone is rapidly excreted in the urine. No evidence of saturation of bone uptake was found after chronic dosing with cumulative IV doses up to 35 mg/kg in animals. Although no clinical information is available, it is likely that, as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function. Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see 4.2 'Posology and method of administration').
In test animal species the main target organs for toxicity were kidneys and gastro-intestinal tract. Renal toxicity was seen only at doses >2 mg/kg/day orally (ten times the recommended dose) and was evident only on histological examination as small widely scattered foci of nephritis, with no evidence of effect on renal function. The gastro-intestinal toxicity, seen in rodents only, occurred at doses >2.5 mg/kg/day and appears to be due to a direct effect on the mucosa. There is no additional relevant information.
Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3,256 mg/m2) and 966 mg/kg (2,898 mg/m2) (equivalent to human oral doses* of 27,600 and 48,300 mg), respectively. In males, these values were slightly higher, 626 and 1,280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4,000 mg/m2) (equivalent to a human oral dose* of 10,000 mg).
* Based on a patient weight of 50 kg.
10 mg tablets: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate and carnauba wax.
None known.
3 years.
Do not store above 30°C.
Blisters of opaque white PVC lidded with aluminium foil.
Pack size: 28 tablets.
None.
Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK
10 mg tablets: PL 0025/0326
10 mg tablets: 28 July 1995/ 3 June 2008
October 2011
P.O.M.
© Merck Sharp & Dohme Limited 2011. All rights reserved.
SPC.FSM.11.UK.3440
Paroxetin 1A Farma may be available in the countries listed below.
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| BANM | British Approved Name (Modified) |
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| SPC | Summary of Product Characteristics (UK) |
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In the US, Plaquenil (hydroxychloroquine systemic) is a member of the following drug classes: antimalarial quinolines, antirheumatics and is used to treat Dermatomyositis, Malaria, Malaria Prevention, Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus and Undifferentiated Connective Tissue Disease.
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Bromelaina (DCIT) is also known as Bromelains (Rec.INN)
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| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Preventing nausea and vomiting associated with cancer chemotherapy, radiation treatment, or surgery. It may also be used for other conditions as determined by your doctor.
Ondansetron Solution is a serotonin 5-HT3 receptor blocker. It works by blocking a chemical thought to be a cause of nausea and vomiting in certain situations (eg, chemotherapy).
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Ondansetron Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Ondansetron Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ondansetron Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Ondansetron Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Ondansetron Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; headache; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; wheezing; unusual hoarseness); chest or jaw pain, numbness of an arm or leg,or sudden severe headache or vomiting; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness; skin tingling or numbness; stomach pain; trouble urinating; uncontrolled muscle movements; vision changes or loss.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Ondansetron side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness; slowed/irregular heartbeat; sudden, temporary blindness.
Store Ondansetron Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store the bottle upright. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ondansetron Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Ondansetron Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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Generic Name: chlophedianol, guaifenesin, and phenylephrine (KLOE fe DYE a nol, gwye FEN e sin, and FEN il EFF rin)
Brand Names: Donatussin
Chlophedianol is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of chlophedianol, guaifenesin, and phenylephrine is used to treat stuffy nose, cough, chest congestion, and sinus congestion caused by allergies, the common cold, or the flu.
Chlophedianol, guaifenesin, and phenylephrine may also be used for purposes not listed in this medication guide.
To make sure you can safely use this medicine, tell your doctor if you have any of these other conditions:
diabetes;
epilepsy or other seizure disorder;
cough with mucus, or cough caused by emphysema, or chronic bronchitis;
enlarged prostate or urination problems; or
pheochromocytoma (an adrenal gland tumor).
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.
Cough or cold medicine is usually taken only for a short time until your symptoms clear up.
Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.
Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 severe forms of some of the side effects listed in this medication guide.
Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, slow, or uneven heart rate;
severe dizziness or anxiety, feeling like you might pass out;
mood changes, hallucinations;
severe headache;
tremor, seizure (convulsions);
fever; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).
Less serious side effects may include:
mild dizziness or drowsiness;
mild headache;
diarrhea, constipation, nausea, upset stomach;
sleep problems (insomnia); or
feeling nervous or restless.
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.
There may be other drugs that can interact with chlophedianol, guaifenesin, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Donatussin side effects (in more detail)
Noflamen may be available in the countries listed below.
Meloxicam is reported as an ingredient of Noflamen in the following countries:
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Primpérid may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Primpérid in the following countries:
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Pro Inject may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Closantel is reported as an ingredient of Pro Inject in the following countries:
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Pantoprazol TAD may be available in the countries listed below.
Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantoprazol TAD in the following countries:
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Pantopan may be available in the countries listed below.
Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantopan in the following countries:
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Propranolol Sandoz may be available in the countries listed below.
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Propranolol Sandoz in the following countries:
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Paroxetin ratiopharm may be available in the countries listed below.
Paroxetine is reported as an ingredient of Paroxetin ratiopharm in the following countries:
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paroxetin ratiopharm in the following countries:
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Pantopep may be available in the countries listed below.
Pantoprazole is reported as an ingredient of Pantopep in the following countries:
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Parocetan may be available in the countries listed below.
Paroxetine is reported as an ingredient of Parocetan in the following countries:
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Parocetan in the following countries:
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Sodium Bicarbonate Injection BP Minijet 4.2% w/v
Sodium Bicarbonate BP 4.2% w/v
Sterile aqueous solution for parenteral administration to humans.
For the correction of metabolic acidosis associated with cardiac arrest after other resuscitative measures such as cardiac compression, ventilation, adrenaline and antiarrhythmic agents have been used.
For intravenous administration only.
Adults: the usual dose is 1mmol/kg (2ml/kg 4.2% solution or 1ml/kg 8.4% solution) followed by 0.5mmol/kg (1ml/kg 4.2% solution or 0.5ml/kg 8.4% solution) given at 10 minute intervals.
Children: the usual dose is 1mmol/kg by slow iv injection.
In premature infants and neonates, the 4.2% solution should be used or the 8.4% solution should be diluted 1:1 with 5% dextrose.
Elderly: as for adults.
Administration of sodium bicarbonate is contraindicated in patients with renal failure, metabolic or respiratory alkalosis, hypertension, oedema, congestive heart failure, a history of urinary calculi and coexistent potassium depletion or hypocalcaemia, hypoventilation, chloride depletion or hypernatraemia.
Whenever sodium bicarbonate is used intravenously, arterial blood gas analyses, in particular arterial/venous blood pH and carbon dioxide levels, should be performed before and during the course of treatment to minimise the possibility of overdosage and resultant alkalosis.
Accidental extravascular injection of hypertonic solutions may cause vascular irritation or sloughing. The use of scalp veins should be avoided.
Whenever respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to get rid of excess CO2.
Caution should be used when administering sodium ions to patients receiving corticosteroids or corticotrophin.
Urinary alkalisation will increase the renal clearance of tetracyclines, especially doxycycline but it will increase the half life and duration of action of basic drugs such as quinidine, amphetamines, ephedrine and pseudoephedrine.
Hypochloraemic alkalosis may occur if sodium bicarbonate is used in conjunction with potassium depleting diuretics such as bumetamide, ethacrynic acid, frusemide and thiazides. Concurrent use in patients taking potassium supplements may reduce serum potassium concentration by promoting an intracellular ion shift.
Safe use in pregnancy has not been established. The use of any drug in pregnant or lactating women requires that the expected benefit be carefully weighed against the possible risk to the mother and child.
Patients requiring i.v. sodium bicarbonate are unlikely to be fit enough to breast feed.
Not applicable; this preparation is intended for use only in emergencies.
Alkalosis and/or hypokalaemia may ensue as a result of prolonged use or over-correction of the bicarbonate deficit.
Hyperirritability or tetany may occur caused by rapid shifts of free ionised calcium or due to serum protein alterations arising from pH changes.
Symptoms: metabolic alkalosis accompanied by compensatory hyperventilation, paradoxical acidosis of the cerebrospinal fluid, severe hypokalaemia, hyperirritability and tetany.
Treatment: discontinue the administration of sodium bicarbonate, rebreathe expired air or, if more severe administer calcium gluconate especially if tetany is present. In severe alkalosis, an infusion of 2.14% ammonium chloride is recommended, except in patients with pe-existing hepatic disease. If hypokalaemia is present administer potassium chloride.
Sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis.
Sodium bicarbonate is eliminated principally in the urine and effectively alkalises it.
Not applicable since sodium bicarbonate has been used in clinical practice for many years and its effects in man are well known.
Water for Injection USP
The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided except where compatibility has been previously established; precipitation or haze may result, should this occur, the solution should not be used.
36 months.
Store below 25°C.
The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications.
The 4.2% w/v is available as 10ml.
The container is specially designed for use with the IMS Minijet injector.
International Medication Systems (UK) Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
UK
PL 3265/0001R
Date first granted: 28 February 1991
Date renewed: 29 November 1996
April 2001
POM
Premium Gamba may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Amprolium hydrochloride (a derivative of Amprolium) is reported as an ingredient of Premium Gamba in the following countries:
Azanidazole is reported as an ingredient of Premium Gamba in the following countries:
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Panaxim may be available in the countries listed below.
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Panaxim in the following countries:
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Bantik may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cymiazol is reported as an ingredient of Bantik in the following countries:
Cypermethrin is reported as an ingredient of Bantik in the following countries:
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Loratab may be available in the countries listed below.
Loratadine is reported as an ingredient of Loratab in the following countries:
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Paroxetin Alternova may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paroxetin Alternova in the following countries:
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Pontizoc may be available in the countries listed below.
Simvastatin is reported as an ingredient of Pontizoc in the following countries:
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Pharmaniaga Omeprazole may be available in the countries listed below.
Omeprazole is reported as an ingredient of Pharmaniaga Omeprazole in the following countries:
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