Estradiol Servier may be available in the countries listed below.
Estradiol hemihydrate (a derivative of Estradiol) is reported as an ingredient of Estradiol Servier in the following countries:
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Sonalent may be available in the countries listed below.
Azelaic Acid is reported as an ingredient of Sonalent in the following countries:
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In the US, Saizen (somatropin systemic) is a member of the drug class growth hormones and is used to treat Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency and Short Stature for Age.
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Somatropine is reported as an ingredient of Saizen in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
Sultanol-Dosieraerosol may be available in the countries listed below.
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Sultanol-Dosieraerosol in the following countries:
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Cokenzen may be available in the countries listed below.
Candesartan cilexetil (a derivative of Candesartan) is reported as an ingredient of Cokenzen in the following countries:
Hydrochlorothiazide is reported as an ingredient of Cokenzen in the following countries:
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Generic Name: brentuximab (Intravenous route)
bren-TUX-i-mab ve-DOE-tin
Progressive multifocal leukoencephalopathy and/or death may occur, as a result of JC virus infection, in patients receiving brentuximab therapy .
In the U.S.
Available Dosage Forms:
Pharmacologic Class: Mitotic Inhibitor
Brentuximab injection is used to treat a type of cancer called Hodgkin's lymphoma (HL). It is given to patients who have received an autologous stem cell transplant (ASCT) or other cancer treatments that did not work well.
Brentuximab injection is also used to treat patients with systemic anaplastic large cell lymphoma (sALCL). It is used after at least one other cancer medicine was given and did not work well.
Brentuximab interferes with the growth of cancer cells, which are then destroyed by the body. Since the growth of normal body cells may also be affected by brentuximab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.
This medicine is to be administered only by or under the immediate supervision of your doctor.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of brentuximab injection in the geriatric population. Safety and efficacy have not been established.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
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. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
This medicine must be given slowly, so the needle will remain in place for 30 minutes. It is usually given every 3 weeks until your condition improves. You may also receive medicines (e.g., acetaminophen, steroid medicines) to help prevent possible allergic reactions to the injection.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
Do not take this medicine together with bleomycin (Blenoxane®). Using these medicines together may cause serious side effects, such as cough, shortness of breath, troubled breathing, or wheezing
Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
This medicine 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 a fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.
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 while you are receiving this medicine.
Check with your doctor if you notice any signs of fever, chills, sore throat, or painful urination. These could be symptoms of an infection resulting from low white blood cell counts.
This medicine may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
Serious skin reactions can occur during treatment with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
This medicine may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). Talk to your doctor about the benefits of using this medicine and the risk of this infection. Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
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 or vitamin supplements.
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.
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Siropar may be available in the countries listed below.
Piperazine hexahydrate (a derivative of Piperazine) is reported as an ingredient of Siropar in the following countries:
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Sagalon may be available in the countries listed below.
Doxepin hydrochloride (a derivative of Doxepin) is reported as an ingredient of Sagalon in the following countries:
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is 4,7 - Bis(dimethylamino) - 1,4,4a,5,5a,6,11,12a - octahydro - 3,10,12,12a - tetrahydroxy - 1,11 - dioxo - 2 - naphthacenecarboxamide monohydrochloride. The structural formula is represented below:
C23H27N3O7.HCl M. W. 493.94
Each minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn).
The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
The 75 mg and 100 mg capsule shells also contain: black iron oxide.
Following oral administration of minocycline hydrochloride capsules, absorption from the gastrointestinal tract is rapid. Maximum serum concentrations following a single dose of minocycline hydrochloride to normal fasting adult volunteers were attained in 1 to 4 hours. The serum half-life in normal volunteers ranges from approximately 11 hours to 22 hours.
When minocycline hydrochloride capsules were given concomitantly with a meal which included dairy products, the extent of absorption of minocycline hydrochloride capsules was not noticeably influenced. The peak plasma concentrations were slightly decreased and delayed by one hour when administered with food, compared to dosing under fasting conditions.
In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of minocycline when administered to 12 normal volunteers is one-half to one-third that of other tetracyclines.
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracyclines is common.
Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:
AEROBIC GRAM-POSITIVE MICROORGANISMS
Because many strains of the following gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended. Tetracycline antibiotics should not be used for streptococcal diseases unless the organism has been demonstrated to be susceptible. Tetracyclines are not the drug of choice in the treatment of any type of staphylococcal infection.
AEROBIC GRAM-NEGATIVE MICROORGANISMS
Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility tests are especially recommended:
"OTHER" MICROORGANISMS
†When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections caused by the cited microorganisms.
Susceptibility testing should be performed with tetracycline since it predicts susceptibility to minocycline. However, certain organisms (e.g., some staphylococci, and Acinetobacter ssp.) may be more susceptible to minocycline and doxycycline than to tetracycline.
Dilution techniques
Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1,3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of tetracycline powder. The MIC values should be interpreted according to the following criteria:
For testing aerobic gram-negative microorganisms (Enterobacteriaceae), Acinetobacter ssp. and Staphylococcus aureus.
| MIC (µg/mL) | Interpretation |
|---|---|
| ≤ 4.0 | Susceptible (S) |
| 8.0 | Intermediate (I) |
| ≥16.0 | Resistant (R) |
For testing Haemophilus influenzaea and Streptococcus pneumoniaeb:
| MIC (µg/mL) | Interpretation |
|---|---|
| ≤ 2.0 | Susceptible (S) |
| 4.0 | Intermediate (I) |
| ≥ 8.0 | Resistant (R) |
a These interpretative standards are applicable only to broth microdilution susceptibility testing with Haemophilus influenzae using Haemophilus Test Medium. 1
b These interpretative standards are applicable only to broth microdilution susceptibility testing using cation-adjusted Muller-Hinton broth with 2 – 5% lysed horse blood. 1
For testing Neisseria gonorrhoeaec.
| MIC (µg/mL) | Interpretation |
|---|---|
| ≤ 0.25 | Susceptible (S) |
| 0.5–1.0 | Intermediate (I) |
| ≥ 2.0 | Resistant (R) |
c These interpretative standards are applicable only to agar dilution susceptibility testing using GC agar base and 1% defined growth supplements. 1
A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard tetracycline powder should provide the following MIC values:
| Microorganism | MIC Range (µg/mL) |
|---|---|
| Escherichia coli ATCC 25922 | 0.5–2.0 |
| Enterococcus faecalis ATCC 29212 | 8.0–32.0 |
| Staphylococcus aureus ATCC 29213 | 0.25–1.0 |
| Haemophilus influenzae ATCC 49247 | 4.0–32.0 |
| Streptococcus pneumoniae ATCC 49619 | 0.12–0.5 |
| Neisseria gonorrhoeae ATCC 49226 | 0.25–1.0 |
Diffusion techniques
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30µg tetracycline (class disk) or 30µg minocycline to test the susceptibility of microorganisms to minocycline. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30µg tetracycline or minocycline disk should be interpreted according to the following criteria:
For testing aerobic gram-negative microorganisms (Enterobacteriaceae) Acinetobacter ssp. and Staphylococcus aureus:
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 19 | Susceptible (S) |
| 15–18 | Intermediate (I) |
| ≤ 14 | Resistant (R) |
For testing Haemophilus influenzaed:
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 29 | Susceptible (S) |
| 26–28 | Intermediate (I) |
| ≤ 25 | Resistant (R) |
d These zone diameter standards are applicable only to susceptibility testing with Haemophilus influenzae using Haemophilus Test Medium and a 30µg tetracycline disk.2
For testing Neisseria gonorrhoeaee:
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 38 | Susceptible (S) |
| 31–37 | Intermediate (I) |
| ≤ 30 | Resistant (R) |
e These interpretative standards are applicable only to disk diffusion testing using GC agar and 1% growth supplements, and a 30µg tetracycline disk.2
For testing Streptococcus pneumoniaef:
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 23 | Susceptible (S) |
| 19–22 | Intermediate (I) |
| ≤ 18 | Resistant (R) |
f These interpretative standards are applicable only to disk diffusion testing using Muller-Hinton agar adjusted with 5% sheep blood and a 30µg tetracycline disk.2
For testing Vibrio choleraeg:
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 19 | Susceptible (S) |
| 15–18 | Intermediate (I) |
| ≤ 14 | Resistant (R) |
g These interpretative standards are applicable only to disk diffusion testing performed with a 30µg tetracycline disk.2
Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for tetracycline.
As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30µg tetracycline or minocycline disk should provide the following zone diameters in these laboratory test quality control strains:
| Microorganism | Zone Diameter Range (mm) | |
|---|---|---|
| Tetracycline | Minocycline | |
| Escherichia coli ATCC 25922 | 18–25 | 19–25 |
| Staphylococcus aureus ATCC 25923 | 24–30 | 25–30 |
| Haemophilus influenzae ATCC 49247 | 14–22 | |
| Neisseria gonorrhoeae ATCC 49226 | 30–42 | |
| Streptococcus pneumoniae ATCC 49619 | 27–31 | |
Minocycline Hydrochloride Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:
Minocycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides.
In severe acne, minocycline may be useful adjunctive therapy.
Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.
Oral minocycline is not indicated for the treatment of meningococcal infection.
Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).
This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy.
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported rarely with minocycline.
Central nervous system side effects including lightheadedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued.
As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of tetracycline, the possibility for permanent sequelae exists.
Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.
Prescribing minocycline hydrochloride capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported rarely with use of minocycline.
Patients who experience central nervous system symptoms (see WARNINGS) should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy.
Concurrent use of tetracycline may render oral contraceptives less effective (see Drug Interactions).
Patients should be counseled that antibacterial drugs including minocycline hydrochloride capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride capsules or other antibacterial drugs in the future.
In long-term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.
All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with minocycline should have a follow-up serologic test for syphilis after 3 months.
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and iron-containing preparations.
The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.
Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in in vitro mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline). Segment I (fertility and general reproduction) studies have provided evidence that minocycline impairs fertility in male rats.
(See WARNINGS)
(See WARNINGS)
The effect of tetracyclines on labor and delivery is unknown.
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS).
(See WARNINGS.)
Due to oral minocycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.
Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitus, inflammatory lesions (with monilial overgrowth) in the anogenital region, and increases in liver enzymes have been reported. Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and the parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION).
Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions have been rarely reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and rarely Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS). Pigmentation of the skin and mucous membranes has been reported.
Elevations in BUN have been reported and are apparently dose related (see WARNINGS). Acute renal failure has been rarely reported and, in most cases, has been reversible.
Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and rarely pulmonary infiltrates with eosinophilia have been reported. A lupus-like syndrome and serum sickness-like reactions also have been reported.
Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults (see PRECAUTIONS-General) have been reported. Headache has also been reported.
When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid glands. Very rare cases of abnormal thyroid function have been reported.
Tooth discoloration in pediatric patients less than 8 years of age (see WARNINGS) and also, rarely, in adults has been reported.
Tinnitus and decreased hearing have been rarely reported in patients on minocycline hydrochloride.
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Minocycline hydrochloride capsules may be taken with or without food. (see CLINICAL PHARMACOLOGY.)
The usual dosage of minocycline hydrochloride capsules is 4 mg/kg initially followed by 2 mg/kg every 12 hours.
The usual dosage of minocycline hydrochloride is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule four times daily.
Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of four days, with post-therapy cultures within 2 to 3 days.
In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for five days is recommended.
For the treatment of syphilis, the usual dosage of minocycline hydrochloride capsules should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.
In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for five days.
Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.
Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least seven days.
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.
In patients with renal impairment (see WARNINGS), the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses.
Dynacin® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 50 mg minocycline are opaque white capsules imprinted "0487" and "Dynacin® 50 mg" and are supplied as follows:
NDC 99207-487-10 Bottles of 100
NDC 99207-487-11 Bottle of 1000.
Dynacin® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 75 mg minocycline are light gray opaque capsules imprinted "0489" and "Dynacin® 75 mg" and are supplied as follows:
NDC 99207-489-10 Bottles of 100
NDC 99207-489-11 Bottle of 1000.
Dynacin® (MINOCYCLINE HCl CAPSULES, USP) equivalent to 100 mg minocycline are opaque dark gray and opaque white capsules imprinted "0488" and "Dynacin® 100 mg" and are supplied as follows:
NDC 99207-488-05 Bottles of 50
NDC 99207-488-11 Bottle of 1000.
Dispense in tight, light-resistant container with child-resistant closure.
Store at 20º–25ºC (68º–77ºF). [See USP Controlled Room Temperature].
Protect from light, moisture and excessive heat.
Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake, and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.
Manufactured for:
MEDICIS, The Dermatology Company®
Scottsdale, AZ 85258
IN-5178/S
Prescribing Information as of February 2004
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Prop.INN
N05BB02
0000486-17-9
C21-H29-N-S2
359
Anxiolytic agent
Ethanamine, 2-[[[4-(butylthio)phenyl]phenylmethyl]thio]-N,N-dimethyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
lir-a-GLOO-tide
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in animals. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Liraglutide is contraindicated in patients with a personal or family history of MTC and Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate risk. Patients should be counseled regarding the risk and symptoms of thyroid tumors .
In the U.S.
Available Dosage Forms:
Pharmacologic Class: Glucagon-Like Peptide-1 Receptor Agonist
Liraglutide injection is used to treat a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. Liraglutide is to be used when diet and exercise do not result in good blood sugar control.
liraglutide is available only with your doctor's prescription.
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 liraglutide, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to liraglutide 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 liraglutide 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 liraglutide in the elderly.
| 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 liraglutide. Make sure you tell your doctor if you have any other medical problems, especially:
When you start using liraglutide, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.
liraglutide should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take liraglutide with or without food.
You will be using liraglutide at home. Your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.
liraglutide is given as a shot under the skin of your stomach, thighs, or upper arm.
Allow the medicine to warm at room temperature before you inject it. If the medicine in the pen has changed color, looks cloudy, or if you see particles in it, do not use it.
Use a new needle each time you inject your medicine.
Never share medicine pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of infection.
Throw away used needles in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.
Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
The dose of liraglutide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of liraglutide. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of liraglutide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store your new, unused medicine pen in the refrigerator, in the original carton, and protect it from light. Do not freeze liraglutide, and do not use the medicine if it has been frozen. You may store the opened medicine pen in the refrigerator or at room temperature for 30 days. Throw away any unused medicine after 30 days.
Remove the needle from the pen before storing the medicine. This prevents leaking of the remaining medicine and prevents air bubbles from forming in the cartridge.
It is very important that your doctor check your progress at regular visits to make sure that liraglutide is working properly. Blood and urine tests may be needed to check for unwanted effects.
It is very important to carefully follow any instructions from your health care team about:
Check with your doctor right away if you have the following symptoms while using liraglutide: a mass in the neck, difficulty with swallowing, hoarseness, shortness of breath, troubled breathing, or wheezing. These may be symptoms of a serious thyroid problem.
Pancreatitis may occur while you are using liraglutide. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
liraglutide does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use liraglutide with other medicines that can lower blood sugar, such as insulin, metformin, or a sulfonylurea. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
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 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: liraglutide Subcutaneous side effects (in more detail)
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Sotropil may be available in the countries listed below.
Piracetam is reported as an ingredient of Sotropil in the following countries:
International Drug Name Search
Rec.INN
C05AX05,C05CX01
0010310-32-4
C29-H34-O6
478
Agent for antivaricose therapy
Capillary stabilizing agent
Sclerosing agent
Antihemorrhoidal agent
D-Glucofuranoside, ethyl 3,5,6-tris-O-(phenylmethyl)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
