Diserinal may be available in the countries listed below.
Ingredient matches for Diserinal
Alfacalcidol
Alfacalcidol is reported as an ingredient of Diserinal in the following countries:
- Italy
International Drug Name Search
Thursday, 29 September 2016
Dismolan
Dismolan may be available in the countries listed below.
Ingredient matches for Dismolan
Ondansetron
Ondansetron is reported as an ingredient of Dismolan in the following countries:
- Venezuela
Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Dismolan in the following countries:
- Argentina
International Drug Name Search
Flomist
Flomist may be available in the countries listed below.
Ingredient matches for Flomist
Fluticasone
Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Flomist in the following countries:
- Oman
- South Africa
- Sri Lanka
International Drug Name Search
Wednesday, 28 September 2016
Difix
Difix may be available in the countries listed below.
Ingredient matches for Difix
Calcitriol
Calcitriol is reported as an ingredient of Difix in the following countries:
- Italy
International Drug Name Search
Denosyl
Denosyl may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Denosyl
Ademetionine
Ademetionine is reported as an ingredient of Denosyl in the following countries:
- Australia
- New Zealand
International Drug Name Search
Gyne-Lotrimin
In the US, Gyne-Lotrimin (clotrimazole topical) is a member of the drug class vaginal anti-infectives and is used to treat Vaginal Yeast Infection.
US matches:
- Gyne-Lotrimin 3 Cream
- Gyne-Lotrimin Cream
- Gyne-Lotrimin Inserts
- Gyne-Lotrimin
- Gyne-Lotrimin 3 Day
- Gyne-Lotrimin Combo Pack
Ingredient matches for Gyne-Lotrimin
Clotrimazole
Clotrimazole is reported as an ingredient of Gyne-Lotrimin in the following countries:
- United States
International Drug Name Search
Emergen
Emergen may be available in the countries listed below.
Ingredient matches for Emergen
Sertraline
Sertraline is reported as an ingredient of Emergen in the following countries:
- Peru
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Emergen in the following countries:
- Chile
International Drug Name Search
Phenix
Phenix may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Phenix
Chlortetracycline
Chlortetracycline is reported as an ingredient of Phenix in the following countries:
- South Africa
Oxytetracycline
Oxytetracycline is reported as an ingredient of Phenix in the following countries:
- South Africa
International Drug Name Search
Boots Indigestion Relief Tablets Fruit
Boots Indigestion Relief Tablets Fruit
(Calcium Carbonate)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.
- Keep this leaflet, you may need to read it again
- Ask your pharmacist if you need more information or advice
What this medicine is for
This medicine contains Calcium Carbonate which belongs to a group of medicines called antacids that act to neutralise excess acid in the stomach.
It can be used to relieve the symptoms of indigestion, heartburn, acidity and wind.
Before you take this medicine
This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
Do not take:
If you have high blood calcium levels
If you have kidney stones or kidney problems
If you have an overactive parathyroid gland
If you suffer from Zollinger-Ellison syndrome, a rare disease which causes frequent stomach ulcers
If you are on a low phosphate diet
If you are taking heart medicines such as digoxin
If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains dextrose)
Talk to your pharmacist or doctor:
- If you are pregnant
Other important information
Breastfeeding: You can take this medicine if you are breastfeeding.
Information about some of the ingredients in this medicine:
Each tablet contains between 521 and 525 mg dextrose. This should be taken into account by people with diabetes.
The colour Ponceau 4R (E124) or sunset yellow (E110) in this medicine may cause an allergic reaction.
If you take other medicines
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
- Water tablets
- Tetracycline antibiotics (for infections)
- Bisphosphonates (for bone problems)
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.
How to take this medicine
Check the foil is not broken before use. If it is, do not take that tablet.
Adults and children of 12 years and over: Take one or two tablets when you need to. Don’t take more than 16 tablets in 24 hours.
Pregnant women: Take one or two tablets when you need to. Don’t take more than 7 tablets in 24 hours.
Suck or chew the tablets.
Do not give to children under 12 years.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
If you take too many tablets: Talk to a pharmacist or doctor.
Possible side effects
Most people will not have problems, but some may get some of these:
- Constipation, wind
- Changes in blood chemistry which may cause you to feel tired, irritable or have stiff muscles or cramp
- Return of indigestion when you stop taking the tablets
If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.
How to store this medicine
Do not store above 25°C.
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton.
What is in this medicine
Each tablet contains Calcium Carbonate 500 mg, which is the active ingredient.
As well as the active ingredient, the tablets also contain dextrose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate, sodium saccharin, quinoline yellow (E104), sunset yellow (E110), ponceau 4R (E124), patent blue V (E131), flavours (orange or cherry or lemon or blackcurrant).
The pack contains 48 tablets. The pack contains a mixture of orange, yellow, pink and purple fruit flavoured tablets.
Who makes this medicine
Manufactured for
The Boots Company PLC
Nottingham
NG2 3AA
by the
Marketing Authorisation holder
Wrafton Laboratories Limited
Braunton Devon
EX33 2DL
Leaflet prepared February 2008
If you would like any further information about this medicine, please contact
The Boots Company PLC
Nottingham
NG2 3AA
Other formats
To request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Boots Indigestion Relief Tablets Fruit Flavour
Reference number: 12063/0013
This is a service provided by the Royal National Institute of the Blind.
3726eMC
Dompéridone Almus
Dompéridone Almus may be available in the countries listed below.
Ingredient matches for Dompéridone Almus
Domperidone
Domperidone is reported as an ingredient of Dompéridone Almus in the following countries:
- France
International Drug Name Search
Borbalan
Borbalan may be available in the countries listed below.
Ingredient matches for Borbalan
Amoxicillin
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Borbalan in the following countries:
- Spain
International Drug Name Search
Tuesday, 27 September 2016
Dartocin
Dartocin may be available in the countries listed below.
Ingredient matches for Dartocin
Lincomycin
Lincomycin hydrochloride monohydrate (a derivative of Lincomycin) is reported as an ingredient of Dartocin in the following countries:
- Dominican Republic
International Drug Name Search
Children's Allergy
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
Uses
• temporarily relieves:
• runny nose • sneezing
• itchy, watery eyes due to hay fever or other
upper respiratory allergies
• itching of the nose or throat
Do Not Use
• to make a child sleepy
• if you are on a sodium-restricted diet
• with any other product containing diphenhydramine,
including one applied topically.
Ask a doctor before use if you have
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or
chronic bronchitis
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
• marked drowsiness may occur
• sedatives and tranquilizers may increase
drowsiness
• excitability may occur, especially in children
Keep this and all drugs out of the reach of children.
In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.
Directions
• use only enclosed dosing cup designed for use with
this product. Do not use any other dosing device.
• take every 4 to 6 hours
• do not exceed 6 doses in a 24-hour period
age dose
children 6 years to under 12 years 1 to 2 teaspoonfuls (12.5 mg to 25 mg)
children 4 years to under 6 years do not use unless directed by a doctor
children under 4 years do not use
Other information
• each teaspoon contains: sodium 6 mg
• store at controlled room temperature
Inactive ingredients
citric acid, flavors, glycerin, poloxamer 407, purified water, red 33, red 40,
sodium benzoate, sodium chloride, sodium citrate, and sugar
Principal Display Panel
Best Choice Health Care
See New dosing information
Children's Allergy
Antihistamine
Liquid Medication
Relieves Sneezing, runny nose, itchy, watery eyes, itchy throat
Cherry flavored
alcohol free
antihistamine
Diphenhydramine HCI
4 fl oz 118mL
| CHILDRENS ALLERGY diphenhydramine hydrochloride liquid | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 04/28/2009 | |
| Labeler - Best Choice (868703513) |
| Registrant - Aaron Industries, Inc. (101896231) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Aaron Industries, Inc. | 101896231 | manufacture, analysis | |
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Salmaplon
Salmaplon may be available in the countries listed below.
Ingredient matches for Salmaplon
Salbutamol
Salbutamol is reported as an ingredient of Salmaplon in the following countries:
- India
International Drug Name Search
Monday, 26 September 2016
Dogminth
Dogminth may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Dogminth
Pyrantel
Pyrantel embonate (a derivative of Pyrantel) is reported as an ingredient of Dogminth in the following countries:
- Belgium
- Luxembourg
International Drug Name Search
Silol
Silol may be available in the countries listed below.
Ingredient matches for Silol
Dimeticone
Dimeticone is reported as an ingredient of Silol in the following countries:
- Poland
International Drug Name Search
Exemastane 25mg film-coated tablets
1. Name Of The Medicinal Product
Exemestane 25mg film-coated tablets
2. Qualitative And Quantitative Composition
Each film-coated tablet contains 25mg exemestane.
Excipients:
Contains 0.4mg glucose (as monohydrate)
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Film-coated tablet.
Yellow film-coated biconvex round tablets, debossed with 'E9MT' on one side and '25' on the other side.
4. Clinical Particulars
4.1 Therapeutic Indications
Exemestane is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2 – 3 years of initial adjuvant tamoxifen therapy.
Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status.
4.2 Posology And Method Of Administration
Adult and elderly patients
The recommended dose of exemestane is one film-coated tablet (25mg) to be taken orally once a day, after a meal.
In patients with early breast cancer, treatment with exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by exemestane), or earlier if tumour relapse occurs.
In patients with advanced breast cancer, treatment with exemestane should continue until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2).
Children and adolescents
Not recommended for use in children and adolescents
4.3 Contraindications
Exemestane is contraindicated in
– pre-menopausal women.
– pregnant or lactating women.
– patients with hypersensitivity to the active substance or to any of the excipients.
4.4 Special Warnings And Precautions For Use
Exemestane should not be administered to women with pre-menopausal endocrine status.
Therefore, whenever clinically appropriate, the post-menopausal status should be ascertained by assessment of LH, FSH and oestradiol levels.
Exemestane should be used with caution in patients with hepatic or renal impairment.
Patients with rare glucose-galactose malabsorption should not take this medicine.
Exemestane is a potent oestrogen lowering agent, and a reduction in bone mineral density and an increased fracture rate has been observed following administration (see section 5.1). During adjuvant treatment with exemestane, women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally assessed by bone densitometry at the commencement of treatment. Although adequate data to show the effects of therapy in the treatment of the bone mineral density loss caused by exemestane are not available, treatment for osteoporosis should be initiated in at risk patients. Patients treated with exemestane should be carefully monitored.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In vitro evidence showed that the drug is metabolised through cytochrome P450 (CYP) 3A4 and aldoketoreductases (see 5.2) and does not inhibit any of the major CYP isoenzymes. In a clinical pharmacokinetic study, the specific inhibition of CYP 3A4 by ketoconazole showed no significant effects on the pharmacokinetics of exemestane.
In an interaction study with rifampicin, a potent CYP450 inducer, at a dose of 600mg daily and a single dose of exemestane 25mg, the AUC of exemestane was reduced by 54% and Cmax by 41%. Since the clinical relevance of this interaction has not been evaluated, the co-administration of drugs, such as rifampicin, anticonvulsants (e.g. phenytoin and carbamazepine) and herbal preparations containing hypericum perforatum (St John's Wort) known to induce CYP3A4 may reduce the efficacy of exemestane.
Exemestane should be used cautiously with drugs that are metabolised via CYP3A4 and have a narrow therapeutic window. There is no clinical experience of the concomitant use of exemestane with other anticancer drugs.
Exemestane should not be coadministered with oestrogen-containing medicines as these would negate its pharmacological action.
4.6 Pregnancy And Lactation
Pregnancy
No clinical data on exposed pregnancies are available with exemestane. Studies on animals have shown reproductive toxicity (See section 5.3). The potential risk for humans is unknown. Exemestane is therefore contraindicated in pregnant women.
Lactation
It is not known whether exemestane is excreted into human milk. Exemestane should not be administered to lactating woman.
Women of perimenopausal status or child-bearing potential
The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including women who are perimenopausal or who have recently become postmenopausal, until their postmenopausal status is fully established (see sections 4.3 and 4.4).
4.7 Effects On Ability To Drive And Use Machines
Drowsiness, somnolence, asthenia and dizziness have been reported with the use of the drug. Patients should be advised that, if these events occur, their physical and/or mental abilities required for operating machinery or driving a car may be impaired.
4.8 Undesirable Effects
Exemestane was generally well tolerated across all clinical studies conducted with exemestane at a standard dose of 25mg/day, and undesirable effects were usually mild to moderate.
The withdrawal rate due to adverse events was 7.4% in patients with early breast cancer receiving adjuvant treatment with exemestane following initial adjuvant tamoxifen therapy.
The most commonly reported adverse reactions were hot flushes (22%), arthralgia (18%) and fatigue (16%).
The withdrawal rate due to adverse events was 2.8% in the overall patient population with advanced breast cancer. The most commonly reported adverse reactions were hot flushes (14%) and nausea (12%).
Most adverse reactions can be attributed to the normal pharmacological consequences of oestrogen deprivation (eg hot flushes).
The reported adverse reactions are listed below by system organ class and by frequency.
Frequencies are defined as: very common (
Table 1:
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(*) Includes: arthralgia, and less frequently pain in limb, osteoarthritis, back pain, arthritis, myalgia and joint stiffness
Blood and lymphatic system disorders
In patients with advanced breast cancer thrombocytopenia and leucopenia have been rarely reported. An occasional decrease in lymphocytes has been observed in approximately 20% of patients receiving exemestane, particularly in patients with pre-existing lymphopenia; however, mean lymphocyte values in these patients did not change significantly over time and no corresponding increase in viral infections was observed.
These effects have not been observed in patients treated in early breast cancer studies.
Hepatobiliary disorders
Elevation of liver function test parameters including enzymes, bilirubin and alkaline phosphatase has been observed.
The table below presents the frequency of pre-specified adverse events and illnesses in the early breast cancer study (IES), irrespective of causality, reported in patients receiving trial therapy and up to 30 days after cessation of trial therapy.
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In the IES study, the frequency of ischemic cardiac events in the exemestane and tamoxifen treatment arms was 4.5% versus 4.2%, respectively. No significant difference was noted for any individual cardiovascular event including hypertension (9.9% versus 8.4%), myocardial infarction (0.6% versus 0.2%) and cardiac failure (1.1% versus 0.7%).
In the IES study, exemestane was associated with a greater incidence of hypercholesterolemia compared with tamoxifen (3.7% vs. 2.1%).
In a separate double blinded, randomized study of postmenopausal women with early breast cancer at low risk treated with exemestane (N=73) or placebo (N=73) for 24 months , exemestane was associated with an average 7-9% mean reduction in plasma HDL-cholesterol, versus a 1% increase on placebo. There was also a 5-6% reduction in apolipoprotein A1 in the exemestane group versus 0-2% for placebo. The effect on the other lipid parameters analysed (total cholesterol, LDL cholesterol, triglycerides, apolipoprotein-B and lipoprotein-a) was very similar in the two treatment groups. The clinical significance of these results is unclear.
In the IES study, gastric ulcer was observed at a higher frequency in the exemestane arm compared to tamoxifen (0.7% versus <0.1%). The majority of patients on exemestane with gastric ulcer received concomitant treatment with non-steroidal anti-inflammatory agents and/or had a prior history.
Adverse reactions from post-marketing experience
Hepatobiliary disorders: Hepatitis, cholestatic hepatitis
Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
4.9 Overdose
Clinical trials have been conducted with exemestane given up to 800mg in a single dose to healthy female volunteers and up to 600mg daily to postmenopausal women with advanced breast cancer; these dosages were well tolerated. The single dose of exemestane that could result in life-threatening symptoms is not known. In rats and dogs, lethality was observed after single oral doses equivalent respectively to 2000 and 4000 times the recommended human dose on a mg/m2 basis. There is no specific antidote to overdosing and treatment must be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated. In case of an overdose, the effects will be consistent with the known side effects of exemestane (see section 4.8).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: hormone antagonists and related agents, enzyme inhibitors
ATC: L02BG06
Exemestane is an irreversible, steroidal aromatase inhibitor, structurally related to the natural substrate androstenedione. In post-menopausal women, oestrogens are produced primarily from the conversion of androgens into oestrogens through the aromatase enzyme in peripheral tissues. Oestrogen deprivation through aromatase inhibition is an effective and selective treatment for hormone dependent breast cancer in postmenopausal women. In postmenopausal women, exemestane p.o. significantly lowered serum oestrogen concentrations starting from a 5mg dose, reaching maximal suppression (>90%) with a dose of 10-25mg. In postmenopausal breast cancer patients treated with the 25mg daily dose, whole body aromatization was reduced by 98%.
Exemestane does not possess any progestogenic or oestrogenic activity. A slight androgenic activity, probably due to the 17-hydro derivative, has been observed mainly at high doses. In multiple daily doses trials, exemestane had no detectable effects on adrenal biosynthesis of cortisol or aldosterone, measured before or after ACTH challenge, thus demonstrating its selectivity with regard to the other enzymes involved in the steroidogenic pathway.
Glucocorticoid or mineralocorticoid replacements are therefore not needed. A non dose-dependent slight increase in serum LH and FSH levels has been observed even at low doses: this effect is, however, expected for the pharmacological class and is probably the result of feedback at the pituitary level due to the reduction in oestrogen levels that stimulate the pituitary secretion of gonadotropins also in postmenopausal women.
Adjuvant Treatment of Early Breast Cancer
In a multicentre, randomised, double-blind study, conducted in 4724 postmenopausal patients with oestrogen-receptor-positive or unknown primary breast cancer, patients who had remained disease-free after receiving adjuvant tamoxifen therapy for 2 to 3 years were randomised to receive 3 to 2 years of exemestane (25mg/day) or tamoxifen (20 or 30mg/day) to complete a total of 5 years of hormonal therapy.
After a median duration of therapy of about 30 months and a median follow-up of about 52 months, results showed that sequential treatment with exemestane after 2 to 3 years of adjuvant tamoxifen therapy was associated with a clinically and statistically significant improvement in disease-free survival (DFS) compared with continuation of tamoxifen therapy. Analysis showed that in the observed study period exemestane reduced the risk of breast cancer recurrence by 24% compared with tamoxifen (hazard ratio 0.76; p=0.00015). The beneficial effect of exemestane over tamoxifen with respect to DFS was apparent regardless of nodal status or prior chemotherapy.
Exemestane also significantly reduced the risk of contralateral breast cancer (hazard ratio 0.57, p=0.04158).
In the whole study population, a trend for improved overall survival was observed for exemestane (222 deaths) compared to tamoxifen (262 deaths) with a hazard ratio 0.85 (log-rank test: p = 0.07362), representing a 15% reduction in the risk of death in favor of exemestane. A statistically significant 23% reduction in the risk of dying (hazard ratio for overall survival 0.77; Wald chi square test: p = 0.0069) was observed for exemestane compared to tamoxifen when adjusting for the pre specified prognostic factors (i.e., ER status, nodal status, prior chemotherapy, use of HRT and use of bisphosphonates). Main efficacy results in all patients (intention to treat population) and oestrogen receptor positive patients are summarised in the table below:
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* Log-rank test; ER+ patients = oestrogen receptor positive patients;
a Disease-free survival is defined as the first occurrence of local or distant recurrence, contralateral breast cancer, or death from any cause;
b Breast cancer free survival is defined as the first occurrence of local or distant recurrence, contralateral breast cancer or breast cancer death;
c Distant recurrence free survival is defined as the first occurrence of distant recurrence or breast cancer death;
d Overall survival is defined as occurrence of death from any cause.
In the additional analysis for the subset of patients with oestrogen receptor positive or unknown status, the unadjusted overall survival hazard ratio was 0.83 (log-rank test: p =0.04250), representing a clinically and statistically significant 17% reduction in the risk of dying. Results from a bone substudy demonstrated that women treated with exemestane following 2 to 3 years of tamoxifen treatment experienced moderate reduction in bone mineral density. In the overall study, the treatment emergent fracture incidence evaluated during the 30 months treatment period was higher in patients treated with exemestane compared with tamoxifen (4.5% and 3.3% correspondingly, p=0.038).
Results from an endometrial substudy indicate that after 2 years of treatment there was a median 33% reduction of endometrial thickness in the exemestane-treated patients compared with no notable variation in the tamoxifen-treated patients. Endometrial thickening, reported at the start of study treatment, was reversed to normal (< 5 mm) for 54% of patients treated with exemestane.
Treatment of Advanced Breast Cancer
In a randomised peer reviewed controlled clinical trial, exemestane at the daily dose of 25mg has demonstrated statistically significant prolongation of survival, Time to Progression (TTP), Time to Treatment Failure (TTF) as compared to a standard hormonal treatment with megestrol acetate in postmenopausal patients with advanced breast cancer that had progressed following, or during, treatment with tamoxifen either as adjuvant therapy or as first-line treatment for advanced disease.
5.2 Pharmacokinetic Properties
Absorption
After oral administration of exemestane tablets, exemestane is absorbed rapidly. The fraction of the dose absorbed from the gastrointestinal tract is high. The absolute bioavailability in humans is unknown, although it is anticipated to be limited by an extensive first pass effect. A similar effect resulted in an absolute bioavailability in rats and dogs of 5%. After a single dose of 25mg, maximum plasma levels of 18mg/ml are reached after 2 hours. Concomitant intake with food increases the bioavailability by 40%.
Distribution
The volume of distribution of exemestane, not corrected for the oral bioavailability, is ca 20000 l. The kinetics is linear and the terminal elimination half-life is 24 h. binding to plasma proteins is 90% and is concentration independent. Exemestane and its metabolites do not bind to red blood cells.
Exemestane does not accumulate in an unexpected way after repeated dosing.
Metabolism and excretion
Exemestane is metabolised by oxidation of the methylene moiety on the 6 position by CYP 3A4 isoenzyme and/or reduction of the 17-keto group by aldoketoreductase followed by conjugation. The clearance of exemestane is ca 500 l/h, not corrected for the oral bioavailability.
The metabolites are inactive or the inhibition of aromatase is less than the parent compound.
The amount excreted unchanged in urine is 1% of the dose. In urine and faeces equal amounts (40%) of 14C-labeled exemestane were eliminated within a week.
Special populations
Age: No significant correlation between the systemic exposure of exemestane and the age of subjects has been observed.
Renal insufficiency:
In patients with severe renal impairment (CLcr < 30 ml/min) the systemic exposure to exemestane was 2 times higher compared with healthy volunteers.
Given the safety profile of exemestane, no dose adjustment is considered to be necessary.
Hepatic insufficiency:
In patients with moderate or severe hepatic impairment the exposure of exemestane is 2-3 fold higher compared with healthy volunteers. Given the safety profile of exemestane, no dose adjustment is considered to be necessary.
5.3 Preclinical Safety Data
Toxicological studies: Findings in the repeat dose toxicology studies in rat and dog were generally attributable to the pharmacological activity of exemestane, such as effects on reproductive and accessory organs. Other toxicological effects (on liver, kidney or central nervous system) were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Mutagenicity: Exemestane was not genotoxic in bacteria (Ames test), in V79 Chinese hamster cells, in rat hepatocytes or in the mouse micronucleus assay. Although exemestane was clastogenic in lymphocytes in vitro, it was not clastogenic in two in vivo studies.
Reproductive toxicology: Exemestane was embryotoxic in rats and rabbits at systemic exposure levels similar to those obtained in humans at 25mg/day. There was no evidence of teratogenicity.
Carcinogenicity: In a two-year carcinogenicity study in female rats, no treatment-related tumors were observed. In male rats the study was terminated on week 92, because of early death by chronic nephropathy. In a two-year carcinogenicity study in mice, an increase in the incidence of hepatic neoplasms in both genders was observed at the intermediate and high doses (150 and 450mg/kg/day). This finding is considered to be related to the induction of hepatic microsomal enzymes, an effect observed in mice but not in clinical studies. An increase in the incidence of renal tubular adenomas was also noted in male mice at the high dose (450mg/kg/day). This change is considered to be species- and gender-specific and occurred at a dose which represents 63-fold greater exposure than occurs at the human therapeutic dose. None of these observed effects is considered to be clinically relevant to the treatment of patients with exemestane.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Core:
Mannitol (E421)
Hypromellose
Crospovidone
Polysorbate 80
Cellulose, microcrystalline
Sodium starch glycolate
Magnesium stearate
Silica, Colloidal Anhydrous
Coating Ingredients:
Carmellose Sodium (E466)
Maltodextrin
Glucose Monohydrate
Titanium dioxide (E171)
Stearic acid (E570)
Iron oxide yellow (E172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
30 months.
6.4 Special Precautions For Storage
This medicinal product does not require any special storage conditions.
6.5 Nature And Contents Of Container
PVC/PVDC:Aluminium blisters in carton boxes containing:
30, 90, 100 and 120 tablets; unit-dose of 30 (30x1) tablets
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
Winthrop Pharmaceuticals UK Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
8. Marketing Authorisation Number(S)
PL 17780/0572
9. Date Of First Authorisation/Renewal Of The Authorisation
02/06/2011
10. Date Of Revision Of The Text
29/08/2011
Docamoxici
Docamoxici may be available in the countries listed below.
Ingredient matches for Docamoxici
Amoxicillin
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Docamoxici in the following countries:
- Belgium
International Drug Name Search
Lasectil
Lasectil may be available in the countries listed below.
Ingredient matches for Lasectil
Omeprazole
Omeprazole is reported as an ingredient of Lasectil in the following countries:
- Vietnam
International Drug Name Search
Aténolol RPG
Aténolol RPG may be available in the countries listed below.
Ingredient matches for Aténolol RPG
Atenolol
Atenolol is reported as an ingredient of Aténolol RPG in the following countries:
- France
International Drug Name Search
Cepacol Extra Strength
Generic Name: benzocaine topical (BENZ oh kane TOP ik al)
Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B
What is Cepacol Extra Strength (benzocaine topical)?
Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.
Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.
There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.
Benzocaine topical may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Cepacol Extra Strength (benzocaine topical)?
There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.
Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.
Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.
Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).
Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.
Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.
Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.
If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.
What should I discuss with my health care provider before using Cepacol Extra Strength (benzocaine topical)?
Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
asthma, bronchitis, emphysema, or other breathing disorder;
heart disease;
a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or
if you smoke.
FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.
How should I use Cepacol Extra Strength (benzocaine topical)?
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.
Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.
Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.
This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.
To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.
Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.
Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.
If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.
Store at room temperature away from moisture and heat. Do not freeze.
What happens if I miss a dose?
Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).
What should I avoid while taking Cepacol Extra Strength (benzocaine topical)?
Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.
Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.
Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.
Cepacol Extra Strength (benzocaine topical) side effects
Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.
Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:
headache, tired feeling, confusion;
fast heart rate;
feeling light-headed or short of breath; and
pale, blue, or gray appearance of your skin, lips, or fingernails.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzocaine topical and call your doctor at once if you have any of these other serious side effects:
headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);
severe burning, stinging, or sensitivity where the medicine is applied;
swelling, warmth, or redness; or
oozing, blistering, or any signs of infection.
Less serious side effects may include:
mild stinging, burning, or itching where the medicine is applied;
skin tenderness or redness; or
dry white flakes where the medicine was applied.
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.
What other drugs will affect Cepacol Extra Strength (benzocaine topical)?
It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. 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.
More Cepacol Extra Strength resources
- Cepacol Extra Strength Side Effects (in more detail)
- Cepacol Extra Strength Use in Pregnancy & Breastfeeding
- 0 Reviews for Cepacol Extra Strength - Add your own review/rating
- Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)
- Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information
- Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information
- Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)
- OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
- Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information
Compare Cepacol Extra Strength with other medications
- Oral and Dental Conditions
- Tonsillitis/Pharyngitis
Where can I get more information?
- Your pharmacist can provide more information about benzocaine topical.
See also: Cepacol Extra Strength side effects (in more detail)
Deroxen
Deroxen may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Deroxen
Chlorhexidine
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Deroxen in the following countries:
- Italy
International Drug Name Search
Kalcij-folinat Pliva
Kalcij-folinat Pliva may be available in the countries listed below.
Ingredient matches for Kalcij-folinat Pliva
Calcium Folinate
Calcium Folinate is reported as an ingredient of Kalcij-folinat Pliva in the following countries:
- Bosnia & Herzegowina
- Croatia (Hrvatska)
International Drug Name Search
Daosin
Daosin may be available in the countries listed below.
Ingredient matches for Daosin
Glibenclamide
Glibenclamide is reported as an ingredient of Daosin in the following countries:
- Bangladesh
International Drug Name Search
Cimetag
Cimetag may be available in the countries listed below.
Ingredient matches for Cimetag
Cimetidine
Cimetidine is reported as an ingredient of Cimetag in the following countries:
- Austria
- Bahrain
- Israel
- Oman
International Drug Name Search
Depo-Provera Contraceptive
Generic Name: medroxyprogesterone (Intramuscular route)
me-drox-ee-proe-JES-ter-one AS-e-tate
Intramuscular route(Suspension)
Women who use medroxyprogesterone acetate injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. Medroxyprogesterone acetate should not be used as a long-term birth control method (ie, longer than 2 years) unless other birth control methods are considered inadequate .
Commonly used brand name(s)
In the U.S.
- Depo-Provera
- Depo-Provera Contraceptive
Available Dosage Forms:
- Injectable
- Suspension
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Medroxyprogesterone
Uses For Depo-Provera Contraceptive
Medroxyprogesterone injection is used to prevent pregnancy. It is a birth control method that works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.
This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is to be administered only by or under the immediate supervision of your doctor.
Before Using Depo-Provera Contraceptive
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Pediatric
Appropriate studies on the relationship of age to the effects of medroxyprogesterone injection have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.
Geriatric
Appropriate studies on the relationship of age to the effects of medroxyprogesterone injection have not been performed in the geriatric population. This medicine should not be used in elderly women.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
Breast Feeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Isotretinoin
- Theophylline
- Tizanidine
- Tranexamic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alprazolam
- Amoxicillin
- Ampicillin
- Amprenavir
- Aprepitant
- Atazanavir
- Bacampicillin
- Betamethasone
- Bexarotene
- Bosentan
- Carbamazepine
- Colesevelam
- Cyclosporine
- Darunavir
- Delavirdine
- Doxycycline
- Efavirenz
- Etravirine
- Fosamprenavir
- Fosaprepitant
- Fosphenytoin
- Griseofulvin
- Lamotrigine
- Licorice
- Minocycline
- Modafinil
- Mycophenolate Mofetil
- Mycophenolic Acid
- Nelfinavir
- Nevirapine
- Oxcarbazepine
- Oxytetracycline
- Phenobarbital
- Phenytoin
- Pioglitazone
- Prednisolone
- Primidone
- Rifabutin
- Rifampin
- Rifapentine
- Ritonavir
- Rosuvastatin
- Rufinamide
- Selegiline
- St John's Wort
- Telaprevir
- Tetracycline
- Topiramate
- Troglitazone
- Troleandomycin
- Voriconazole
- Warfarin
Interactions with Food/Tobacco/Alcohol
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Blood clots, or history of or
- Breast cancer, known or suspected or
- Liver disease, significant or
- Pregnancy or
- Problems with circulation or blood clots, now or in the past or
- Stroke, history of—Should not be used in patients with these conditions.
- Asthma or
- Depression, history of or
- Fluid retention (edema or body swelling) or
- Heart disease or
- Hypertension (high blood pressure) or
- Kidney disease or
- Migraine headaches (severe headache)
- Osteoporosis, current or risk factors for—Use with caution. May make these conditions worse.
Proper Use of medroxyprogesterone
This section provides information on the proper use of a number of products that contain medroxyprogesterone. It may not be specific to Depo-Provera Contraceptive. Please read with care.
To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.
This medicine comes with patient information insert. Read them carefully and make sure you understand them before receiving this medicine. If you have any questions, ask your doctor.
A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given as a shot into one of your muscles (usually in the buttocks or upper arm).
Your doctor must make sure you are not pregnant before you start treatment with this medicine. For most women, this means you must receive your first shot during the first 5 days of a normal menstrual period. You will need to receive this medicine every 3 months (12 to 14 weeks). Be sure to keep all appointments with your doctor to receive your injections.
If you plan to start this medicine after having a baby, you should receive your first shot within 5 days after your baby is born. If you plan to breastfeed your new baby, talk to your doctor about when to get your first shot. Some doctors may suggest waiting 6 weeks before getting your first shot, but others may suggest getting the shot sooner after the baby is born. If you wait 6 weeks, talk to your doctor about using an alternative form of birth control.
If you are switching from another method of birth control, carefully follow your doctor’s instructions about when to have your first injection of this medicine.
You need to have enough calcium and vitamin D in your diet. Your doctor might suggest that you take supplements.
Missed Dose
Call your doctor or pharmacist for instructions.
You must have this shot every 12 to 14 weeks to prevent pregnancy. If you do not get another shot after 14 weeks, talk with your doctor. You may need to use another form of birth control and wait until your next menstrual period before starting the shots again.
Precautions While Using Depo-Provera Contraceptive
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 3 months, but some doctors require them more often. Your doctor will check your blood pressure once a year.
Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause your bones to lose calcium, which can lead to osteoporosis (thin or weak bones). This calcium loss could continue the whole time you are receiving this medicine. Your bones should start to rebuild calcium after you stop using this medicine. This is more of a concern if you are a teenager, smoke or drink alcohol regularly, have other bone problems, anorexia nervosa (an eating disorder), a family history of osteoporosis, or use other medicines that also affect your bones (such as steroids or medicine to treat seizures).
You will need to talk with your doctor if you want to use this medicine for more than 2 years. You might need to be tested to make sure your bones are not losing too much calcium.
Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using this medicine.
Check with your doctor immediately if you have blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
There is a very slight chance that this medicine could increase risk of breast cancer in some women. Talk to your doctor about this risk. Make sure your doctor knows if anyone in your family has had breast cancer.
Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after receiving this medicine. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.
Most women have changes in their menstrual periods while using this medicine. You might have irregular bleeding, spotting, or heavier or lighter periods. Many women stop having periods. Call your doctor if you have very heavy or nonstop bleeding.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.
Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause fluid retention (edema) and weight gain in some patients. Tell your doctor right away if you have bloating or swelling of face, arms, hands, lower legs, or feet; tingling of hands or feet; or unusual weight gain or loss.
If you plan to have children after you stop using this medicine, it may take up to year or longer before you can become pregnant. However, do not depend on this medicine to prevent pregnancy for more than 13 weeks.
This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections. If this is a concern for you, talk with your doctor.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
Depo-Provera Contraceptive Side Effects
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:
More common
- Absent, missed, or irregular menstrual periods
- menstrual changes
- stopping of menstrual bleeding
- Breast pain
- cramps
- heavy bleeding
- increased clear or white vaginal discharge
- itching of the vagina or genital area
- pain during sexual intercourse
- swelling
- thick, white vaginal discharge with no odor or with a mild odor
- Abdominal or stomach pain
- anxiety
- black, tarry stools
- blood in the stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- changes in skin color
- chest pain
- chills
- clay-colored stools
- clear or bloody discharge from the nipple
- cough
- dark urine
- decrease in height
- difficult or labored breathing
- difficulty with breathing
- difficulty with swallowing
- dimpling of the breast skin
- dizziness or lightheadedness
- dull ache or feeling of pressure or heaviness in the legs
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever
- headache
- hives
- increased thirst
- inverted nipple
- itching
- itching skin near damaged veins
- loss of appetite
- lump in the breast or under the arm
- nausea
- no sensation in the legs
- noisy breathing
- pain in the back, ribs, arms, or legs
- pain, redness, tenderness, or swelling of the arm, foot, or leg
- pale skin
- persistent crusting or scaling of the nipple
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rash
- redness or swelling of the breast
- shortness of breath
- skin rash
- sore on the skin of the breast that does not heal
- sudden shortness of breath or troubled breathing
- swollen feet and ankles
- tightness in the chest
- troubled breathing with exertion
- unable to move the legs
- unpleasant breath odor
- unusual bruising or bleeding
- unusual tiredness or weakness
- vomiting of blood
- wheezing
- yellow eyes or skin
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:
More common
- Abdominal or stomach discomfort
- decreased interest in sexual intercourse
- inability to have or keep an erection
- increased weight
- loss in sexual ability, desire, drive, or performance
- nervousness
- Backache
- blemishes on the skin
- bloating
- depression
- difficulty with moving
- feeling of warmth
- hair loss or thinning of the hair
- lack or loss of strength
- leg cramps
- muscle pain or stiffness
- pain in the joints
- pimples
- redness of the face, neck, arms, and occasionally, upper chest
- sleeplessness
- sudden sweating
- trouble sleeping
- unable to sleep
- Brown, blotchy spots on the exposed skin
- changes in appetite
- diarrhea
- drowsiness
- dry skin
- hoarseness
- increased hair growth, especially on the face
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sweating and body odor
- indigestion
- loss of appetite
- pain at the injection site
- passing of gas
- patchy brown or dark brown discoloration of the skin
- stomach pain, fullness, or discomfort
- swelling of the armpits
- unexpected or excess milk flow from breasts
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: Depo-Provera Contraceptive side effects (in more detail)
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More Depo-Provera Contraceptive resources
- Depo-Provera Contraceptive Side Effects (in more detail)
- Depo-Provera Contraceptive Use in Pregnancy & Breastfeeding
- Depo-Provera Contraceptive Drug Interactions
- 4 Reviews for Depo-Provera Contraceptive - Add your own review/rating
- Depo-Provera Prescribing Information (FDA)
- Depo-Provera Injectable Suspension MedFacts Consumer Leaflet (Wolters Kluwer)
- Depo-Provera Consumer Overview
- Depo-SubQ Provera 104 Prescribing Information (FDA)
- Medroxyprogesterone Prescribing Information (FDA)
- Medroxyprogesterone MedFacts Consumer Leaflet (Wolters Kluwer)
- Medroxyprogesterone Acetate Monograph (AHFS DI)
- Provera Prescribing Information (FDA)
- depo-subQ provera 104 Injectable Suspension (Subcutaneous) MedFacts Consumer Leaflet (Wolters Kluwer)
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