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Class: Ergot-derivative Dopamine Receptor Agonists
ATC Class: G02CB01
VA Class: AU900
CAS Number: 22260-51-1
Brands: Parlodel
Ergot-derivative dopamine receptor agonist and prolactin inhibitor.a b
Treatment of male and female dysfunctions associated with hyperprolactinemia, including amenorrhea and/or galactorrhea, hypogonadism, and infertility.a b
Used in patients with prolactin-secreting adenomas (e.g., prolactinoma), including macroadenomas, to decrease tumor size; may be used prior to surgery in patients undergoing excision of the tumor (adenectomy).a b
Treatment of female infertility associated with hyperprolactinemia; used to induce ovulation in appropriately selected anovulatory women.b
Treatment of hypogonadism and galactorrhea that persist following radiation therapy or surgery in hyperprolactinemic males with prolactin-secreting adenomas and adequate testosterone concentrations.a b Some clinicians consider bromocriptine the treatment of choice for reduction of large tumors (macroadenomas).b
Symptomatic management of idiopathic or postencephalitic parkinsonian syndrome.a b
Used as an adjunct to levodopa for the symptomatic management of parkinsonian syndrome in patients with advanced disease.111 112 a
Has been used as monotherapy for initial symptomatic management of parkinsonian syndrome†.111 Most clinicians would use levodopa for initial therapy in individuals >70 years of age (less likely than younger individuals to develop levodopa-related motor complications and because of concerns about cognitive dysfunction), in patients with cognitive impairment, and in those with severe disease.111 A dopamine receptor agonist may be preferred for initial therapy in patients ≤70 years of age.111
Treatment of acromegaly, alone or as adjunctive therapy with pituitary irradiation or surgery.a b
Has been used to increase sperm counts and restore fertility† in oligospermic men without hyperprolactinemia who are unresponsive to traditional drug therapy.b
Has been used to relieve extrapyramidal reactions, hyperthermia, and hypertension of neuroleptic malignant syndrome† (NMS) associated with neuroleptic drug therapy (e.g., haloperidol, fluphenazine).b
Has been used in the management of chronic hepatic encephalopathy†.b
Used in the past for prevention of postpartum breast engorgement†;106 b FDA has withdrawn approval of bromocriptine for this indication because the risk of serious, potentially fatal adverse effects100 102 104 107 108 outweigh the limited benefits associated with this use.101 103 (See Cardiovascular Effects under Cautions.)
Individualize and adjust dosage carefully; evaluate frequently during dosage adjustment to determine lowest therapeutic dosage.a b
Temporary dosage reduction or discontinuance may be necessary in patients developing intolerable adverse effects.b
When bromocriptine is discontinued (i.e., during pregnancy) in patients being treated for hyperprolactinemic disorders, monitor patients for tumor progression or development.b (See Warnings: Pregnancy under Cautions.)
During initial therapy for female infertility, use a mechanical contraceptive in conjunction with bromocriptine therapy until normal ovulatory menstrual cycles have been restored; contraception can then be discontinued.a b
If menstruation does not occur within 3 days of the expected date, discontinue bromocriptine and perform a pregnancy test.a b
Assess patient’s therapeutic response at 2-week intervals to ensure lowest effective dosage is not exceeded.a b
Determine serum growth hormone concentrations monthly, and adjust bromocriptine dosage based on the reduction in these concentrations and the patient’s clinical response.a b
If an adequate response is not apparent after a brief trial with the drug and/or dosage adjustment and clinical evaluation, consider discontinuance of bromocriptine.a b
Withdraw therapy (4- to 8-week period is usually adequate) annually in patients undergoing radiation therapy of the pituitary to determine if continued therapy with the drug and/or radiation is necessary.a b If signs and/or symptoms of acromegaly recur or growth hormone concentrations increase during this period, consider additional bromocriptine therapy.a b
Administer orally with food.a b
Available as bromocriptine mesylate; dosage expressed in terms of bromocriptine.a
Children ≥11 years of age: Initially, 1.25–2.5 mg daily.a May increase as tolerated until therapeutic response achieved.a Usual dosage range is 2.5–10 mg daily.a
Initially, 1.25–2.5 mg daily.a b May increase dosage by 2.5 mg every 2–7 days, as tolerated, until therapeutic response achieved.a Usual dosage range is 2.5–15 mg daily;a up to 30 mg daily has been required in some patients with amenorrhea and/or galactorrhea.b
Initially, 1.25–2.5 mg daily.a b May increase dosage by 2.5 mg every 2–7 days, as tolerated, until therapeutic response achieved.a Usual dosage range is 2.5–15 mg daily;a up to 40 mg daily has been required in some patients.b
Initially, 1.25–2.5 mg daily.b May increase dosage by 2.5 mg every 2–7 days, as tolerated, until therapeutic response achieved.a Usual dosage range is 2.5–15 mg daily.a
Initially, 1.25 mg twice daily with meals.a b If needed, may increase dosage by 2.5 mg daily every 14–28 days; do not exceed 100 mg daily.a b
If levodopa dosage reduced because of adverse effects, may increase daily dosage of bromocriptine gradually in 2.5-mg increments.a b
Initially, 1.25–2.5 mg at bedtime for 3 days.a b May increase dosage by 1.25–2.5 mg daily at 3- to 7-day intervals, as tolerated, until desired therapeutic benefit achieved.a b
Reevaluate patients monthly, adjust dosage based on reduction of growth hormone or clinical response.a b Usual dosage range is 20–30 mg daily; do not exceed 100 mg daily.a b Dosages of 20–60 mg have been administered daily in divided doses.b
2.5–5 mg 2–6 times daily.b
Initially, 1.25 mg daily; increase dosage by 1.25 mg daily every third day up to a total maintenance dosage of 15 mg daily.b
Safety of dosages >100 mg daily not established.a b
Maximum 100 mg daily.a b Safety of therapy for >2 years not established.a b
Decreased clearance; dosage adjustment may be necessary.a (See Elimination under Pharmacokinetics)
Uncontrolled hypertension.a b (See Cardiovascular Effects under Cautions.)
Known sensitivity to ergot alkaloids.a b
Known hypersensitivity to bromocriptine or any ingredient in the formulation.a
Mechanical contraceptive measures recommended for women not seeking pregnancy or those with large adenomas.a b Perform pregnancy test every 4 weeks in amenorrheic women and, once menses are reinstated, whenever a menstrual period is missed.a b
Possible sudden enlargement of underlying prolactin-secreting pituitary tumors in women with hyperprolactinemic disorders who become pregnant and discontinue bromocriptine therapy; may result from normal increases in pituitary size during pregnancy.a b May cause optic nerve compression, visual impairment, or blindness, which usually disappear after delivery; regular visual field checks recommended.a b Diabetes insipidus and pituitary apoplexy also may occur.a b Prior to initiating therapy for amenorrhea/galactorrhea and infertility, carefully evaluate the pituitary including gadolinium-enhanced MRI to rule out pituitary tumors.a b c
Discontinue therapy immediately if pregnancy occurs during therapy for hyperprolactinemic disorders and carefully observe women throughout pregnancy for signs and symptoms of tumor progression.a b If reinstitution of therapy is required to control a rapidly expanding macroadenoma and a hypertensive disorder associated with pregnancy occurs, consider risks and benefits of continuing bromocriptine therapy.a (See Cardiovascular Effects under Cautions.)
If pregnancy occurs in a woman receiving therapy for acromegaly or parkinsonian syndrome, discontinue therapy unless bromocriptine therapy is medically necessary.a If therapy is continued and a hypertensive disorder of pregnancy occurs, discontinue therapy unless bromocriptine withdrawal is medically contraindicated.a b
Only continue bromocriptine during the postpartum period in women with a cardiovascular disease history if withdrawal is considered medically contraindicated; carefully observe the patient.a
Episodes of falling asleep while engaged in activities of daily living, sometimes without warning or awareness, have been reported, particularly in patients with parkinsonian syndrome.a Consider dosage reduction or treatment discontinuance if these effects occur.a
Symptomatic hypotension reported, especially during initial treatment; use caution, especially during the first days of treatment.a b
Hypertension (sometimes developing with initiation of therapy but often during the second week), seizures, and potentially fatal strokes reported, mostly in postpartum women.a Acute MI reported rarely.a
Seizures and strokes usually preceded by a constant and severe headache hours to days prior to event and may be preceded by visual disturbances (blurred vision, transient cortical blindness).a b
Discontinue therapy immediately and evaluate patient promptly if hypertension; severe, progressive, or unremitting headache (with or without visual disturbances); or evidence of CNS toxicity occurs.a b
Periodic monitoring of BP recommended, especially during the first few weeks of therapy.a
Use with caution in patients with a history of cardiovascular disease or MI with residual atrial, nodal, or ventricular arrhythmia.a b
Pleural and pericardial effusions, constrictive pericarditis, and pleural and pulmonary fibrosis reported, especially in patients receiving high-dose, long-term therapy; usually resolves slowly with discontinuance of therapy.a b Consider discontinuance of therapy if these disorders occur.a
Observe patients receiving long-term (e.g., 6–36 months), high-dose (e.g., 20–100 mg daily) therapy for pulmonary changes (e.g., infiltrates, effusion, and thickening of the pleura).a b Thoroughly evaluate unexplained pleuropulmonary disorders and consider discontinuance of therapy.a
Retroperitoneal fibrosis reported rarely in patients receiving long-term (e.g., 2–10 years), high-dose (30–140 mg daily) therapy.a b Monitor for manifestations (e.g., back pain, lower extremity edema, impaired kidney function); discontinue therapy if fibrotic changes are diagnosed or suspected.a
Confusion and mental disturbances may occur in patients with parkinsonian syndrome receiving high-dose therapy; usually resolve within 2–3 weeks after discontinuance.a Use caution in patients who manifest mild dementia.a
Visual or auditory hallucinations reported in patients with parkinsonian syndrome; hallucinations usually resolve following dosage reduction, but discontinuance of drug may occasionally be necessary.a b Rarely, hallucinations may persist for several weeks following discontinuance of the drug.a b Use with caution in patients with a history of psychosis.a
CSF rhinorrhea reported rarely in patients with prolactin-secreting adenomas who previously underwent transsphenoidal surgery and/or radiation therapy and who were receiving the drug for tumor recurrence; may also occur in patients with previously untreated prolactinoma that extends into the sphenoid sinus.a b
Use not recommended in patients with galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.a
Secondary visual field loss due to chiasmal herniation may occur in patients with macroprolactinoma effectively treated for hyperprolactinemia.a b Monitor patients and consider decreasing dosage if this occurs.a
Relative efficacy of bromocriptine therapy versus surgery in preserving the visual fields in patients with hyperprolactinemic disorders not known.a b Patients with rapidly progressing visual field loss should be evaluated by a neurosurgeon.a b
Cold-sensitive digital vasospasm reported in patients being treated for acromegaly; usually resolves following a reduction in dosage and may be prevented by keeping fingers warm.a
Possible expansion of growth hormone-secreting tumors in patients with acromegaly.a b Careful monitoring recommended; if evidence of tumor expansion occurs, discontinue therapy and consider alternative therapies.a b
Evaluate hepatic, hematopoietic, cardiovascular, and renal function periodically in patients receiving prolonged therapy with bromocriptine (e.g., treatment of parkinsonian syndrome).a
Severe GI bleeding from peptic ulcers, sometimes fatal, reported in patients with acromegaly.a b Closely monitor patients with a history of peptic ulcer or GI bleeding.a b Thoroughly evaluate signs and symptoms of peptic ulcer; institute appropriate therapy if necessary.a b
Category B.a (See Warnings: Pregnancy under Cautions.)
Use not recommended in nursing women because bromocriptine interferes with lactation.a b
Safety and efficacy established for children ≥16 years of age for treatment of prolactin-secreting adenomas.a However, bromocriptine has been evaluated in well-controlled clinical trials in children ≥11 years of age.a
Safety and efficacy not established for other uses.a
Insufficient experience in clinical trials with patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; consider age-related decreases in hepatic, renal, or cardiac function in this population.a b
Use with caution; safety and efficacy not established.a b Reduced dosage may be required.a b
Use with caution; safety and efficacy not established.a b
Patients with hyperprolactinemia: Nausea, headache, fatigue, dizziness, lightheadedness, vomiting, abdominal cramps, constipation, diarrhea, drowsiness, nasal congestion.a
Patients with acromegaly: Nausea, constipation, postural/orthostatic hypotension, anorexia, dry mouth/nasal stuffiness, indigestion/dyspepsia, digital vasospasm, drowsiness.a
Patients with parkinsonian syndrome: Nausea, involuntary movements, hallucinations, confusion, “on-off” episodes, dizziness, drowsiness, faintness/fainting, vomiting, asthenia, abdominal discomfort, visual disturbance, ataxia, insomnia, depression, hypotension, shortness of breath, constipation, vertigo.a
Metabolized principally by CYP3A; potent inhibitor of CYP3A4.a
Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma bromocriptine concentrations).a
Potent substrates of CYP3A4: Potential pharmacokinetic interaction (increased plasma substrate concentrations).a However, not expected to alter metabolism of CYP3A4 substrates, due to low free concentrations of bromocriptine.a
Potential inhibition of bromocriptine's effectiveness in reducing serum prolactin concentrations.a
Drug | Interaction | Comments |
|---|---|---|
Alcohol | May potentiate adverse effects of bromocriptinea Possible decreased alcohol toleranceb | Limit alcohol intakea b |
Antidepressants, tricyclics (amitriptyline, imipramine) | Potential reduced efficacy of bromocriptine b | Consider increasing bromocriptine dosageb |
Antifungals, azoles | Possible interference with bromocriptine metabolisma | Use concomitantly with cautiona |
Antihypertensives | Potential additive hypotensive effectsa b | Careful adjustment of antihypertensive dosage may be necessarya b Use with cautiona b |
Antipsychotic agents (haloperidol, phenothiazines) | Possible reduced efficacy of bromocriptinea b | Increased bromocriptine dosage may be required if used concomitantlyb |
Butyrophenones (e.g., droperidol) | Potential reduced bromocriptine concentrationsa b | Consider increasing bromocriptine dosageb |
Dopamine antagonists (e.g., metoclopromide, pimozide) | Possible reduced efficacy of bromocriptinea | |
Ergot alkaloids | Potential for severe adverse effects (e.g., hypertension, myocardial infarction)a b (see Cardiovascular Effects under Cautions) | Concomitant use not recommendeda b |
HIV protease inhibitors | Possible interference with bromocriptine metabolisma | Use concomitantly with cautiona |
Levodopa | Potential additive therapeutic and neurologic effectsb | May be used to therapeutic advantage; consider decreasing levodopa dosageb |
Macrolide antibiotics (e.g., erythromycin) | Increased plasma bromocriptine concentrationsa | |
Methyldopa | Possible reduced efficacy of bromocriptineb | Increased bromocriptine dosage may be required if used concomitantlyb |
Octreotide | Increased concentrations of bromocriptinea | |
Reserpine | Possible reduced efficacy of bromocriptinea b | Increased bromocriptine dosage may be required if used concomitantlyb |
Absolute bioavailability 28%, with peak plasma concentration usually attained within 1–3 hours.a
Following oral administration, onset of prolactin-lowering effect begins within 1–2 hours of ingestion, with maximal benefit within 5–10 hours.a Parkinsonian effects may begin 30–90 minutes after ingestion, with maximal benefit within approximately 2 hours.b
Maximum prolactin-lowering effects generally persist for 8–12 hours.a
Does not distribute appreciably into erythrocytes.a b
90–96% (mainly albumin).a
Undergoes extensive first-pass biotransformation in the liver, primarily via CYP3A and hydroxylation, to form inactive metabolites.a b
Bromocriptine and its metabolites eliminated principally (85%) in feces via biliary excretion and to a lesser extent (6%) in urine.a b
Biphasic; terminal half-life is approximately 15 hours.a
Hepatic impairment decreases elimination, resulting in increased plasma bromocriptine concentrations.a
Tight, light-resistant containers at <25°C.a
A dopamine receptor agonist that activates postsynaptic dopamine receptors that modulate the secretion of prolactin from the anterior pituitary. a
Substantially reduces serum prolactin concentrations by inhibiting release of prolactin from the anterior pituitary gland; directly affects the pituitary and/or stimulates postsynaptic dopamine receptors in the hypothalamus to release prolactin-inhibitory factor via a complicated catecholamine pathway.b
Causes transient increases in somatropin (growth hormone) secretion in individuals with normal growth hormone concentrations; paradoxically causes sustained suppression of growth hormone secretion in patients with acromegaly.a b
Relieves symptoms of parkinsonism by directly stimulating dopamine receptors in the corpus striatum;a b dysregulation of brain serotonin activity may also occur.b
Risk of dizziness, drowsiness, or faintness; use caution when driving or operating machinery.a b
Risk of somnolence; possibility of falling asleep during activities of daily living.a b If this occurs, patients should not drive or participate in potentially dangerous activities until episodes resolve.a b
Importance of immediately informing clinician if persistent watery nasal discharge occurs in patients being treated for macroadenoma or in patients who have had recent transsphenoidal surgery.a
Advise patients being treated for macroadenoma that discontinuance of bromocriptine may result in rapid regrowth of tumor and recurrence of original symptoms.a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses, such as hypertension or hypotension.a
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b
Importance of using a method of contraception and monitoring regular pregnancy tests in patients treated for amenorrhea, as pregnancy may occur prior to the return of menses.a
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 5 mg (of bromocriptine)* | Bromocriptine Mesylate Tablets | Sandoz |
Parlodel | Novartis | |||
Tablets | 2.5 mg (of bromocriptine)* | Bromocriptine Mesylate Tablets | Lek, Sandoz | |
Parlodel SnapTabs (with povidone; scored) | Novartis |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Bromocriptine Mesylate 2.5MG Tablets (MYLAN): 30/$64.99 or 90/$174.97
Bromocriptine Mesylate 5MG Capsules (MYLAN): 30/$135.99 or 90/$385.97
Parlodel 2.5MG Tablets (NOVARTIS): 30/$165.99 or 90/$497.98
Parlodel 5MG Capsules (NOVARTIS): 30/$259.99 or 90/$709.96
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
100. Anon. Sandoz withdrawing Parlodel postpartum lactation suppression indication. Prescription Pharm Biotechnol. 1994; 56(Aug 22):T&G1-2.
101. Anon. Bromocriptine indication withdrawn. FDA Med Bulletin. 1994; 24:2.
102. Anon. Sandoz will halt promotion of bromocriptine for suppression of lactation. Am J Hosp Pharm. 1994; 51:2626.
103. Hartwig SC, Smeenk DA, Michaels MR. Drug-use evaluation program for postpartum bromocriptine therapy. Am J Hosp Pharm. 1990; 47:2514-5. [PubMed 2278264]
104. Larrazet F, Spaulding C, Lobreau HJ et al. Possible bromocriptine-induced myocardial infarction. Ann Intern Med. 1993; 118:199-200. [IDIS 308704] [PubMed 8417637]
105. Sandoz, East Hanover, NJ: Personal communication.
106. Sandoz. Parlodel (bromocriptine mesylate) Snap-Tabs tablets and capsules prescribing information dated Sep 1993. In: Physicians’ desk reference. 49th ed. Montvale, NJ: Medical Economics Company, Inc. 1994:2178-80.
107. Rothman KJ, Funch DP, Dreyer NA. Bromocriptine and puerperal seizures. Epidemiology. 1990; 1:232-8. [PubMed 2081258]
108. Eickman FM. Recurrent myocardial infarction in a postpartum patient receiving bromocriptine. Clin Cardiol. 1992; 15:781-3. [PubMed 1395192]
109. Gittelman D. Bromocriptine associated with postpartum hypertension, seizures, and pituitary hemorrhage. Gen Hosp Psychiatry. 1991; 13:278-80. [PubMed 1874430]
110. Food and Drug Administration. Sandoz Pharmaceutical Corp.; Bromocriptine mesylate (Parlodel); withdrawal of approval of the indication for the prevention of physiological lactation. [Docket No. 94N-0304.] Fed Regist. 1995; 60:3404-5.
111. Olanow CW, Watts RL, Koller WC. An algorithm (decision tree) for the management of Parkinson’s disease (2001): treatment guidelines. Neurology. 2001; 56:S1-S88.
112. Anon. Initial treatment of Parkinson’s disease: wait just a minute. Med Lett Drugs Ther. 2001; 43:59-60. [PubMed 11445778]
a. Novartis. Parlodel (bromocriptine mesylate) SnapTabs tablets and capsules prescribing information. Suffern, NY; 2006 May.
b. AHFS drug information 2006. McEvoy GK, ed. Bromocriptine mesylate. Bethesda, MD: American Society of Health-System Pharmacists; 2006:3610-4.
c. Schleachte, JA. Prolactinoma. NEJM. 2007; 349;21:2035-41.
be-va-SIZ-yoo-mab
Gastrointestinal perforation, some cases fatal, has occurred in up to 2.4% of bevacizumab-treated patients. Discontinue bevacizumab if gastrointestinal perforation or wound dehiscence occurs. Discontinue at least 28 days prior to elective surgery. Do not initiate bevacizumab for at least 28 days after surgery and until the surgical wound is fully healed. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, CNS hemorrhage, and vaginal bleeding, have occurred up to 5-fold more frequently in bevacizumab-treated patients. Do not administer bevacizumab to patients with serious hemorrhage or recent hemoptysis .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immunological Agent
Pharmacologic Class: Monoclonal Antibody
Bevacizumab injection is given with other medicines to treat patients with metastatic (a cancer that has spread) carcinoma of the colon or rectum. bevacizumab is also used to treat a certain type of metastatic lung cancer called non-squamous, non-small cell lung cancer, and a certain type of brain tumor called glioblastoma.
Bevacizumab is a substance that helps the body fight cancer. It prevents the growth of certain types of blood vessels to cancer cells. This helps to decrease the growth of cancer cells by starving the cells of nutrients that are needed to grow.
Bevacizumab is also used in combination with other medicines (e.g., interferon alfa) to treat patients with cancer of the kidney that has spread to other areas of the body.
bevacizumab is to be administered only by or under the immediate supervision of your doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, bevacizumab is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bevacizumab, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to bevacizumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of bevacizumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bevacizumab injection in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel problems, which may require caution in patients receiving bevacizumab injection.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of bevacizumab. Make sure you tell your doctor if you have any other medical problems, especially:
You will receive bevacizumab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you bevacizumab. bevacizumab is given through a needle placed in one of your veins.
Bevacizumab is often given together with other cancer medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor to help you plan a way to remember to take your medicines at the right times.
It is very important that your doctor check your progress at regular visits to make sure that bevacizumab is working properly and to check for unwanted effects. Your doctor will need to check your urine and blood pressure at regular visits while you are receiving bevacizumab. Be sure to keep all appointments. You may be taught how to check your blood pressure at home.
Using bevacizumab while you are pregnant can harm your unborn baby. Use two forms of birth control to keep from getting pregnant. Keep using two forms of birth control for at least 6 months after your treatment ends. If you think you have become pregnant while using the medicine, tell your doctor right away.
bevacizumab may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using bevacizumab. You may need to stop using bevacizumab several weeks before and after having surgery.
bevacizumab may increase your chance of having bleeding problems. Stop using bevacizumab and tell your doctor right away if you start to notice any signs of bleeding.
bevacizumab may increase your chance of having blood clots or a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using bevacizumab and tell your doctor right away if you develop chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are using bevacizumab.
Tell your doctor right away if you are having severe stomach pain accompanied by other symptoms such as constipation, fever, nausea, and vomiting. These could be symptoms of a serious medical condition.
bevacizumab may also increase your risk of having a serious condition called tracheoesophageal fistula (an abnormal opening in one or more places between the esophagus and the trachea). Tell your doctor right away if you start having trouble swallowing, coughing, or choking while eating, trouble breathing, or chest pain or discomfort while you are using bevacizumab.
Bevacizumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Bevacizumab may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.
If you plan to have children, talk with your doctor before using bevacizumab. Some women using bevacizumab have become infertile (unable to have children).
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: bevacizumab Intravenous side effects (in more detail)
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Generic Name: topical emollients (TOP i kal ee MOL i ents)
Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care
Emollients are substances that moisten and soften your skin.
Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.
There are many brands and forms of topical emollients available and not all are listed on this leaflet.
Topical emollients may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:
deep wounds or open sores;
swelling, warmth, redness, oozing, or bleeding;
large areas of skin irritation;
any type of allergy; or
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.
Apply a small amount of topical emollient to the affected area and rub in gently.
If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.
If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.
Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.
Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.
Less serious side effects are more likely, and you may have none at all.
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.
It is not likely that other drugs you take orally or inject will have an effect on topically applied products. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Cefurim eco may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Cefurim eco in the following countries:
International Drug Name Search
Generic Name: brompheniramine and phenylephrine (BROM fen IR a meen and FEN il EFF rin)
Brand Names: Alacol, Alenaze-D, Alenaze-D NR, B-Vex D, BPM PE, Brom Tann PE, Bromfed, Bromfed-PD Capsules, BroveX ADT, BroveX PEB, Brovex-D, Children's Cold & Allergy, Dimaphen Elixir, Dimetapp Cold & Allergy, Entre-B, J-Tan D, J-Tan D SR, Phenyl 15/12mg, Phenyl 7.5/6mg, RespaHist II, Rhinabid, Rhinabid PD, Seradex-LA, Tanabid SR, V-Hist, VazoBid, VaZol-D, Vazotab, Zotex-PE
Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of brompheniramine and phenylephrine is used to treat nasal congestion, sneezing, itching, watery eyes, and runny nose caused by allergies, hay fever, and the common cold.
Brompheniramine and phenylephrine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist about taking brompheniramine and phenylephrine if you have heart disease or high blood pressure, diabetes, a thyroid disorder, glaucoma, kidney disease, an enlarged prostate, or problems with urination.
Ask a doctor or pharmacist if it is safe for you to take brompheniramine and phenylephrine if you have:
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
glaucoma;
kidney disease;
an enlarged prostate; or
problems with urination.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.
The chewable tablet must be chewed before you swallow it.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
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 feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid becoming overheated or dehydrated during exercise and in hot weather.
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, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
drowsiness or dizziness;
blurred vision;
dry mouth, nose, or throat;
mild stomach pain, constipation;
problems with memory or concentration;
feeling restless or excited (especially in children);
sleep problems (insomnia); or
warmth, redness, or tingly feeling under your skin.
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.
Tell your doctor about all other medications you are using, especially:
medicines to treat high blood pressure;
a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and other drugs may interact with brompheniramine and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: BroveX ADT side effects (in more detail)
Ophtagen may be available in the countries listed below.
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Ophtagen in the following countries:
International Drug Name Search