Letrozol-Mepha may be available in the countries listed below.
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Letrozole
Letrozole is reported as an ingredient of Letrozol-Mepha in the following countries:
- Switzerland
International Drug Name Search
Monday, 26 December 2011
Thursday, 22 December 2011
Dianeal PD-1
Dianeal PD-1 peritoneal dialysis solutions in AMBU-FLEX III containers with a flanged port are sterile, nonpyrogenic solutions for intraperitoneal administration only. They contain no bacteriostatic or antimicrobial agents or added buffers.
Composition, calculated osmolarity, pH and ionic concentrations are shown in Table 1.
Potassium is omitted from DIANEAL solutions because dialysis may be performed to correct hyperkalemia. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician. Frequent monitoring of serum electrolytes is indicated.
The osmolarities shown in Table 1 are calculated values. As an example, measured osmolarity by freezing point depression determination of Dianeal PD-1 peritoneal dialysis solution with 1.5% dextrose is approximately 334 mOsmol/L, compared with measured values in normal human serum of 280 mOsmol/L.
The plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly.
Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Dianeal PD-1 - Clinical Pharmacology
Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally excreted by the kidneys, and for aiding in the regulation of fluid and electrolyte balance.
The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit into the peritoneal cavity. With the exception of lactate, present as a bicarbonate precursor, electrolyte concentrations in the fluid have been formulated to attempt to normalize plasma electrolyte concentrations resulting from osmosis and diffusion across the peritoneal membrane (between the plasma of the patient and the dialysis fluid). Toxic substances and metabolites, present in high concentrations in the blood, cross the peritoneal membrane into the dialyzing fluid. Dextrose in the dialyzing fluid is used to produce a solution hyperosmolar to the plasma, creating an osmotic gradient which facilitates fluid removal from the patient’s plasma into the peritoneal cavity. After a period of time (dwell time), the fluid is drained by gravity from the cavity.
Indications and Usage for Dianeal PD-1
Peritoneal dialysis is indicated for patients in acute or chronic renal failure when nondialytic medical therapy is judged to be inadequate (Vaamonde and Perez 1977). It may also be indicated in the treatment of certain fluid and electrolyte disturbances, and for patients intoxicated with certain poisons and drugs (Knepshield et al. 1977). However, for many substances other methods of detoxification have been reported to be more effective than peritoneal dialysis (Vaamonde and Perez 1977; Chang 1977).
Contraindications
Warnings
Peritoneal dialysis should be done with great care, if at all, in patients with a number of abdominal conditions including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, and large polycystic kidneys (Vaamonde and Perez 1977). Other conditions include recent aortic graft replacement and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.
An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences including congestive heart failure, volume depletion, and shock.
Excessive use of Dianeal PD-1 peritoneal dialysis solution with 3.5% or 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.
In acute renal failure patients, plasma electrolyte concentrations should be monitored periodically during the procedure. Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of blood chemistries and hematologic factors, as well as other indicators of patient status.
Not for use in the treatment of lactic acidosis.
Potassium is omitted from Dianeal PD-1 solutions because dialysis may be performed to correct hyperkalemia. Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician.
The use of 5 liters of dialysis solution is not indicated in a single exchange.
Refer to manufacturer’s directions accompanying drugs to obtain full information on additives.
If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added.
After removing overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard the solution because the sterility may be impaired.
Freezing of solution may occur at temperatures below 0°C (32°F). Do not flex or manipulate container when frozen. Allow container to thaw naturally in ambient conditions and thoroughly mix contents by shaking.
Precautions
Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection. If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated.
Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort.
Significant losses of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis.
Replacement therapy should be provided as necessary.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with DIANEAL peritoneal dialysis solutions. It is also not known whether DIANEAL peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DIANEAL peritoneal dialysis solutions should be given to a pregnant woman only if clearly needed.
Do not administer unless solution is clear and seal is intact.
Adverse Reactions
Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a chronic peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions may include electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome and muscle cramping.
Dianeal PD-1 Dosage and Administration
Dianeal PD-1 solutions are intended for intraperitoneal administration only.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The mode of therapy (Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory Peritoneal Dialysis [CAPD], or Continuous Cyclic Peritoneal Dialysis [CCPD]), frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient.
To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange.
Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. (See Directions for Use)
The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis, or when the solution drainage contains fibrinous or proteinaceous material (Ribot et al. 1966). 1000 to 2000 USP units of heparin per liter of solution has been recommended for adults (Furman et al. 1978). For children, 50 units of heparin per 100 mL of dialysis fluid has been recommended (Irwin et al. 1981).
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgement of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
Intermittent Peritoneal Dialysis (IPD)
For dialysis of acute renal failure patients and maintenance dialysis of chronic renal failure patients
The cycle of instillation, dwell and removal of dialysis fluid is repeated sequentially over a period of hours (8 to 36 hours) as many times per week as indicated by the condition of the patient. For chronic renal failure patients, maintenance dialysis is often accomplished by periodic dialysis (3 to 5 times weekly) for shorter time periods (8 to 14 hours per session) (Mattocks and El-Bassiouni 1971).
Continuous Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cyclic Peritoneal Dialysis (CCPD)
For maintenance dialysis of chronic renal failure patients
In CAPD, 1.5 to 3.0 liters of dialysis solution (depending upon patient size) are instilled into the peritoneal cavity of adults and the peritoneal access device is then clamped (Kim et al. 1984; Twardowski and Janicka 1981; Twardowski and Burrows 1984). For children, 30 to 50 mL/kg body weight with a maximum of 2 liters has been recommended (Potter et al. 1981; Irwin et al. 1981). The solution remains in the cavity for dwell times of 4 to 8 hours during the day and 8 to 12 hours overnight. At the conclusion of each dwell period, the access device is opened, the solution drained and fresh solution instilled. The procedure is repeated 3 to 5 times per day, 6 to 7 days per week. Solution exchange volumes and frequency of exchange should be individualized for adequate biochemical and fluid volume control (Moncrief et al. 1982; Twardowski et al. 1983). The majority of exchanges will utilize 1.5% or 2.5% dextrose containing peritoneal dialysis solutions, with 3.5% or 4.25% dextrose containing solutions being used when extra fluid removal is required. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978).
In CCPD, the patient receives 3 or 4 dialysis exchanges during the night which range from 2-1/2 to 3 hours dwell duration. Typically 1.5 to 2.0 liters of dialysis solution (depending upon patient size) are delivered each cycle by an automatic peritoneal dialysis cycler machine. After the last outflow during the night, an additional exchange is infused by the cycler machine into the peritoneum. The equipment is then disconnected from the patient, and the dialysate remains in the peritoneum for 14 to 15 hours during the day until the next nocturnal cycle (Diaz-Buxo et al. 1981). Combinations of 1.5% or 2.5% dextrose containing peritoneal dialysis solutions are usually used for the nighttime exchanges while 3.5% or 4.25% dextrose is used when extra fluid removal is required such as during the daytime exchange. Patient weight is used as the indicator of the need for fluid removal (Popovich et al. 1978) so therapy should be individualized according to the patient’s need for ultrafiltration.
It is recommended that adult patients being placed on chronic peritoneal dialysis or, in the case of pediatric patients, the selected caretaker, (as well as the patient, when suitable), should be appropriately trained in a program which is under the supervision of a physician. Training materials are available from Baxter Healthcare Corporation, Deerfield, IL 60015, USA to facilitate this training.
How is Dianeal PD-1 Supplied
Dianeal PD-1 peritoneal dialysis solutions in AMBU-FLEX III containers are available in nominal size flexible containers with fill volumes and dextrose concentrations as indicated in Table 1.
All Dianeal PD-1 peritoneal dialysis solutions have overfills which are declared on container labeling.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.
Directions for Use
For complete system preparation, see directions accompanying ancillary equipment.
Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad) should be used. Solutions should not be heated in water due to an increased risk of infection. Microwave ovens should not be used to heat solutions because there is a potential for damage to the solution container. Moreover, microwave oven heating may potentially cause overheating and/or non-uniform heating of the solution that may result in patient injury or discomfort.
To Open
Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. If supplemental medication is desired, follow directions below before preparing for administration. Check for minute leaks by squeezing container firmly.
To Add Medication
Additives may be incompatible.
If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added.
- Prepare medication site.
- Using a syringe with a 1 inch long 19 to 25 gauge needle, puncture resealable medication port and inject.
- Position container with ports up and evacuate the medication port by squeezing and tapping it.
- Mix solution and medication thoroughly.
Preparation for Administration
- Place container on table or suspend from support (depending on technique).
- Remove protector from outlet port of container.
- Attach appropriate solution transfer set. Refer to complete directions in hardware manual and/or directions accompanying transfer set.
REFERENCES
- Chang, T.M.S. 1977. Criteria, evaluation, and perspectives of various microencapsulated charcoal hemoperfusion systems. Dial and Transplant 6:50-53.
- Diaz-Buxo, J.A. et al. 1981. Continuous cyclic peritoneal dialysis: a preliminary report. Int Soc Artif Organs 81:157-161.
- Furman, K.l. et al. 1978. Activity of intraperitoneal heparin during peritoneal dialysis. Clin Nephrol 9:15-18.
- Irwin, M.A. et al. 1981. Continuous ambulatory peritoneal dialysis in pediatrics. AANNT J 8:11-13,44.
- Kim, D. et al. 1984. Continuous ambulatory peritoneal dialysis with three-liter exchanges: a prospective study. Peritoneal Dial Bull 4:82-85.
- Knepshield, J.H. et al. 1977. Dialysis of poisons and drugs - update. Trans Am Soc Artif Intern Organs 23:762-842.
- Mattocks, A.M. and El-Bassiouni, E.A. 1971. Peritoneal dialysis: a review. J Pharm Sci 60:1767-1782.
- Moncrief, J.W. et al. 1982. CAPD: Are three exchanges per day adequate? AANNT J 9:39-43.
- Popovich, R.P. et al. 1978. Continuous ambulatory peritoneal dialysis. Ann Intern Med 8:449-456.
- Potter, D.E. et al. 1981. Continuous ambulatory dialysis (CAPD) in children. Trans Am Soc Artif Intern Organs 27:64-67.
- Ribot, S. et al. 1966. Complications of peritoneal dialysis.Am J Med Sci 252:505-517.
- Vaamonde, C.A. and Perez, G.O. 1977. Peritoneal dialysis today.Kidney 10:31-36.
- Twardowski, Z.J. and Janicka, L. 1981. Three exchanges with a 2.5 liter volume for continuous ambulatory peritoneal dialysis. Kidney Int 20:281-284.
- Twardowski, Z.J. et al. 1983. High volume low frequency continuous ambulatory peritoneal dialysis. Kidney Int 23:64-70.
- Twardowski, Z.J. and Burrows, L. 1984. Two year experience with high volume, low frequency continuous ambulatory peritoneal dialysis. Peritoneal Dial Bull 4:S67.
| Table 1 | ||||||||||||||||
| Composition/100 mL | Osmolarity (mOsmol/L) (calc) | pH | Ionic Concentration (mEq/L) | How Supplied | ||||||||||||
| *Dextrose, Hydrous, USP | Sodium Chloride, USP (NaCl) | Sodium Lactate (C3H5NaO3) | Calcium Chloride, USP (CaCl2•2H2O) | Magnesium Chloride, USP (MgCl2•6H2O) | Sodium | Calcium | Magnesium | Chloride | Lactate | Fill Volume (mL) | Container Size (mL) | Code | NDC | |||
| Dianeal® PD-1 Peritoneal Dialysis Solution with 1.5% Dextrose | 1.5 g | 567 mg | 392 mg | 25.7 mg | 15.2 mg | 347 | 5.2 (4.0 to 6.5) | 132 | 3.5 | 1.5 | 102 | 35 | 2000 5000 | 2000 5000 | 5B5136 5B5190 | NDC 09410377‑46 NDC 0941-0377-25 |
| Dianeal® PD-1 Peritoneal Dialysis Solution with 2.5% Dextrose | 2.5 g | 567 mg | 392 mg | 25.7 mg | 15.2 mg | 398 | 5.2 (4.0 to 6.5) | 132 | 3.5 | 1.5 | 102 | 35 | 2000 2000 5000 | 2000 3000 5000 | 5B5146 5B5147 5B5191 | NDC 0941‑0383‑46 NDC 0941-0383-47 NDC 0941-0383-25 |
| Dianeal® PD-1 Peritoneal Dialysis Solution with 4.25% Dextrose | 4.25 g | 567 mg | 392 mg | 25.7 mg | 15.2 mg | 486 | 5.2 (4.0 to 6.5) | 132 | 3.5 | 1.5 | 102 | 35 | 2000 5000 | 3000 5000 | 5B5157 5B5192 | NDC 0941‑0379‑47 NDC 0941-0379-25 |
Baxter, DIANEAL, AMBU-FLEX, and PL 146 are trademarks of Baxter International Inc.
©Copyright 1981, 1982, 1983, 1984, 1989, Baxter Healthcare Corporation. All rights reserved.
| Dianeal PD-1 WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution | ||||||||||||||||||||||||
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| Dianeal PD-1 WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution | ||||||||||||||||||||||||
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| Dianeal PD-1 WITH DEXTROSE sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose injection, solution | ||||||||||||||||||||||||
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Revised: 05/2006Baxter Healthcare Corporation
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Thursday, 15 December 2011
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Mirtazapine
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In some countries, this medicine may only be approved for veterinary use.
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Prednisolone 21-(disodium phosphate) (a derivative of Prednisolone) is reported as an ingredient of Bronal in the following countries:
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Sertraline
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertraline Actavis in the following countries:
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Doxycycline
Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Doxine in the following countries:
- New Zealand
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RotaTeq
Pronunciation: ROE-ta-VI-russ
Generic Name: Rotavirus Oral Vaccine Live
Brand Name: RotaTeq
RotaTeq is used for:
Preventing certain types of rotavirus infection in infants and children.
RotaTeq is a live viral vaccine for rotavirus. RotaTeq works by helping the immune system to protect against rotavirus.
Do NOT use RotaTeq if:
- the patient is allergic to any ingredient in RotaTeq
- the patient has severe combined immunodeficiency disease (SCID)
- the patient has a history of a severe type of blockage or twisting of the intestine (intussusception)
Contact your doctor or health care provider right away if any of these apply to you.
Before using RotaTeq:
Some medical conditions may interact with RotaTeq. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if the patient is pregnant, planning to become pregnant, or are breast-feeding
- if the patient is taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if the patient has allergies to medicines, foods, or other substances
- if the patient has any type of cancer, infection, fever, or other current illness (eg, diarrhea, vomiting)
- if the patient or someone regularly in close contact with the patient has a history of a weakened immune system (eg, HIV infection, AIDS) or certain blood problems (eg, leukemia, lymphoma, cancer of the bone marrow or lymphatic system)
- if the patient or someone regularly in close contact with the patient takes medicine that may weaken the immune system, including an immunosuppressant (eg, cyclosporine) or a corticosteroid (eg, prednisone)
- if the patient has cancer; gastroesophageal reflux disease (GERD); stomach or bowel problems (eg, blockage); chronic diarrhea; a birth defect; or has had stomach or bowel surgery
- if the patient has not been gaining weight or growing as expected
- if the patient has had a recent (within the past 42 days) blood or plasma transfusion, or has received immune globulin
Some MEDICINES MAY INTERACT with RotaTeq. Tell your health care provider if the patient is taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone), immunosuppressants (eg, cyclosporine), or medicines to treat cancer because they may decrease RotaTeq's effectiveness
Ask your health care provider if RotaTeq may interact with other medicines that the patient takes. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use RotaTeq:
Use RotaTeq as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with RotaTeq. Talk to your pharmacist if you have questions about this information.
- Take RotaTeq by mouth with or without food.
- Do not mix this vaccine with any other vaccines or solutions. Do not dilute RotaTeq.
- RotaTeq requires 3 doses. If you miss a dose of RotaTeq, contact your doctor right away.
Ask your health care provider any questions you may have about how to use RotaTeq.
Important safety information:
- RotaTeq may not protect everyone who receives it. Discuss any questions or concerns with your doctor.
- RotaTeq should be used with caution in CHILDREN younger than 6 weeks or older than 32 weeks of age; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: RotaTeq is not approved for use in patients of childbearing age. It is not known if RotaTeq is found in breast milk.
Possible side effects of RotaTeq:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Mild fever, diarrhea, or vomiting; runny nose; sore throat.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; change in bowel movements; ear pain; high fever; red eyes or mouth; severe or persistent stomach pain, diarrhea, or vomiting; swelling of the hands or feet; swollen glands; wheezing or coughing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: RotaTeq side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of RotaTeq:
RotaTeq is usually handled and stored by a health care provider. If you are using RotaTeq at home, store RotaTeq as directed by your pharmacist or health care provider. Protect from light. Keep RotaTeq out of the reach of children and away from pets.
General information:
- If you have any questions about RotaTeq, please talk with your doctor, pharmacist, or other health care provider.
- RotaTeq is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about RotaTeq. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
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Rocephin
Generic Name: ceftriaxone (Injection route)
sef-trye-AX-one
Commonly used brand name(s)
In the U.S.
- Rocephin
Available Dosage Forms:
- Powder for Solution
Therapeutic Class: Antibiotic
Pharmacologic Class: 3rd Generation Cephalosporin
Uses For Rocephin
Ceftriaxone is used to treat bacterial infections in many different parts of the body. This medicine is also given before certain types of surgery to prevent infections.
Ceftriaxone belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
This medicine is available only with your doctor's prescription.
Before Using Rocephin
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ceftriaxone in children. Because of ceftriaxone's toxicity, use in newborn and premature babies is not recommended.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ceftriaxone in the elderly.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Calcium Acetate
- Calcium Chloride
- Calcium Gluceptate
- Calcium Gluconate
- Lactated Ringer's Solution
- Ringer's Solution
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Anemia or
- Diarrhea or
- Gallbladder disease or
- Pancreatitis (inflammation of the pancreas) or
- Stomach or bowel disease (e.g., colitis), history of—Use with caution. May make these conditions worse.
- Hyperbilirubinemia (high bilirubin in the blood)—Should not be used in newborn (less than 28 days of age) and premature infants with this condition.
- Kidney disease or
- Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
- Liver disease, severe or
- Undernourished condition—May be worsened by ceftriaxone and you may need to take Vitamin K.
Proper Use of Rocephin
A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your muscles or through a needle placed in one of your veins.
Precautions While Using Rocephin
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.
Ceftriaxone may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Do not take other medicines unless they have been discussed with your doctor. This includes calcium-containing solutions for injection, prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Rocephin 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
- Black, tarry stools
- chest pain
- chills
- cough
- fever
- painful or difficult urination
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- Diarrhea
- Abdominal or stomach cramps or tenderness
- back, leg, or stomach pains
- bleeding gums
- bloating
- blood in the urine or stools
- bloody nose
- bluish color
- changes in skin color
- clay-colored stools
- convulsions
- cough or hoarseness
- dark urine
- diarrhea, watery and severe, which may also be bloody
- difficulty with breathing
- difficulty with swallowing
- dizziness
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of discomfort
- feeling of warmth
- fever with or without chills
- general body swelling
- general feeling of tiredness or weakness
- headache
- hives
- increased sweating
- increased thirst
- inflammation of the joints
- itching
- loss of appetite
- lower back or side pain
- muscle aches
- nausea or vomiting
- noisy breathing
- nosebleeds
- pain
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rash
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- skin rash
- swelling of the foot or leg
- swollen lymph glands
- tenderness
- tightness in the chest
- troubled breathing with exertion
- unpleasant breath odor
- unusual weight loss
- vomiting of blood
- watery or bloody diarrhea
- wheezing
- yellowing of the eyes or skin
- Blistering, peeling, or loosening of the skin
- chest pain
- coughing up blood
- decrease in the amount of urine
- excessive muscle tone
- increased menstrual flow or vaginal bleeding
- muscle stiffness, tension, or tightness
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- red irritated eyes
- red or black, tarry stools
- red or dark brown urine
- red skin lesions, often with a purple center
- restlessness
- skin rash with a general disease
- swelling
- trouble sitting still
- unpleasant breath odor
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:
Rare
- Acid or sour stomach
- belching
- bloated
- change in taste
- dizziness
- excess air or gas in the stomach or intestines
- full feeling
- headache
- heartburn
- indigestion
- itching of the vagina or genital area
- loss of taste
- pain during sexual intercourse
- passing gas
- stomach discomfort, upset, or pain
- thick, white vaginal discharge with no odor or with a mild odor
- Hives or welts
- redness, swelling, or soreness of the tongue
- swelling or inflammation of the mouth
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: Rocephin side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
More Rocephin resources
- Rocephin Side Effects (in more detail)
- Rocephin Use in Pregnancy & Breastfeeding
- Rocephin Drug Interactions
- Rocephin Support Group
- 23 Reviews for Rocephin - Add your own review/rating
- Rocephin Prescribing Information (FDA)
- Rocephin Consumer Overview
- Rocephin Monograph (AHFS DI)
- Rocephin MedFacts Consumer Leaflet (Wolters Kluwer)
- Ceftriaxone Prescribing Information (FDA)
Compare Rocephin with other medications
- Bacteremia
- Bacterial Endocarditis Prevention
- Bacterial Infection
- Bone infection
- Chancroid
- Conjunctivitis
- Endocarditis
- Endometritis
- Epididymitis, Non-Specific
- Epididymitis, Sexually Transmitted
- Epiglottitis
- Gastroenteritis
- Gonococcal Infection, Disseminated
- Gonococcal Infection, Uncomplicated
- Intraabdominal Infection
- Joint Infection
- Kidney Infections
- Lyme Disease
- Lyme Disease, Arthritis
- Lyme Disease, Carditis
- Lyme Disease, Neurologic
- Meningitis
- Meningococcal Meningitis Prophylaxis
- Neurosyphilis
- Otitis Media
- Pelvic Inflammatory Disease
- Peritonitis
- Pneumonia
- Prostatitis
- Salmonella Gastroenteritis
- Sepsis
- Shigellosis
- Skin and Structure Infection
- Skin Infection
- STD Prophylaxis
- Surgical Prophylaxis
- Syphilis, Early
- Typhoid Fever
- Urinary Tract Infection
Sunday, 16 October 2011
Avelox IV
Avelox IV may be available in the countries listed below.
Ingredient matches for Avelox IV
Moxifloxacin
Moxifloxacin hydrochloride (a derivative of Moxifloxacin) is reported as an ingredient of Avelox IV in the following countries:
- Ireland
- United Kingdom
International Drug Name Search
Tuesday, 11 October 2011
Lattulosio Teva
Lattulosio Teva may be available in the countries listed below.
Ingredient matches for Lattulosio Teva
Lactulose
Lactulose is reported as an ingredient of Lattulosio Teva in the following countries:
- Italy
International Drug Name Search
Thursday, 6 October 2011
Curlem
Curlem may be available in the countries listed below.
Ingredient matches for Curlem
Vecuronium
Vecuronium Bromide is reported as an ingredient of Curlem in the following countries:
- Peru
International Drug Name Search
Monday, 3 October 2011
Roxicet Solution
Pronunciation: OX-i-KOE-done/a-SEET-a-MIN-oh-fen
Generic Name: Oxycodone/Acetaminophen
Brand Name: Roxicet
Roxicet Solution contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.
Roxicet Solution is used for:
Relieving moderate to moderately severe pain. Roxicet Solution may also be used to treat other conditions as determined by your doctor.
Roxicet Solution is a combination of a narcotic and an analgesic/antipyretic. It works in the brain and nervous system to decrease pain.
Do NOT use Roxicet Solution if:
- you are allergic to any ingredient in Roxicet Solution
- you have high blood carbon dioxide levels (hypercarbia) or a certain severe bowel problem (eg, paralytic ileus)
- you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack
- you are taking sodium oxybate (GHB)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Roxicet Solution:
Some medical conditions may interact with Roxicet Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had an allergic reaction to any codeine- or morphine-related medicine (eg, hydrocodone, dihydrocodeine, hydromorphone)
- if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
- if you have or recently have had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or infection of the brain or nervous system
- if you have a history of heart problems (eg, cor pulmonale), low blood pressure, the blood disease porphyria, stomach or bowel problems (eg, blockage, paralysis), inflammation of the pancreas (pancreatitis), gallbladder problems, liver problems (eg, hepatitis), kidney problems, seizures, thyroid problems, adrenal gland problems (eg, Addison disease), curvature of the spine (scoliosis), prostate problems (eg, an enlarged prostate), or trouble urinating
- if you are in very poor health; are dehydrated or have low blood volume; or have drowsiness, stomach pain, or severe diarrhea caused by antibiotic use (pseudomembranous colitis)
- if you drink alcohol; have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or actions; or are going through withdrawal from alcohol or other substances
Some MEDICINES MAY INTERACT with Roxicet Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticholinergics (eg, scopolamine, oxybutynin) because the risk of a certain severe bowel problem (paralytic ileus) may be increased
- Cimetidine, muscle relaxants (eg, cyclobenzaprine), phenothiazines (eg, chlorpromazine), or sulfinpyrazone because the risk of side effects, such as severe drowsiness, slow or difficult breathing, confusion, and seizures, may be increased
- Azole antifungals (eg, itraconazole, ketoconazole), beta-blockers (eg, propranolol), clarithromycin, isoniazid, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Roxicet Solution's side effects
- Buprenorphine, butorphanol, nalbuphine, naltrexone, pentazocine, or rifamycins (eg, rifampin) because they may decrease Roxicet Solution's effectiveness
- Lamotrigine, loop diuretics (eg, furosemide), or zidovudine because their effectiveness may be decreased by Roxicet Solution
- Anticoagulants (eg, warfarin) or sodium oxybate (GHB) because the risk of their side effects may be increased by Roxicet Solution
- Medicines that may harm the liver (eg, acetaminophen, methotrexate, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if Roxicet Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Roxicet Solution:
Use Roxicet Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Roxicet Solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you have been taking Roxicet Solution regularly or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose.
- If Roxicet Solution is no longer needed, dispose of the unused medicine by flushing it down the toilet.
- If you miss a dose of Roxicet Solution and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Roxicet Solution.
Important safety information:
- Roxicet Solution may cause dizziness, light-headedness, blurred vision, or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Roxicet Solution. Using Roxicet Solution alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
- Roxicet Solution may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not drink alcohol while you are taking Roxicet Solution.
- Check with your doctor before you take medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using Roxicet Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or take more often than prescribed without checking with your doctor.
- Tell your doctor or dentist that you take Roxicet Solution before you receive any medical or dental care, emergency care, or surgery.
- Roxicet Solution may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Roxicet Solution, talk with your doctor or pharmacist.
- Roxicet Solution may harm your liver. Your risk may be greater if you drink alcohol while you are using Roxicet Solution. Talk to your doctor before you take Roxicet Solution or other fever reducers if you drink alcohol.
- Roxicet Solution has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.
- Roxicet Solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Roxicet Solution.
- Use Roxicet Solution with caution in the ELDERLY; they may be more sensitive to its side effects, especially breathing problems and drowsiness.
- Use Roxicet Solution with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Roxicet Solution while you are pregnant. Roxicet Solution is found in breast milk. Do not breast-feed while taking Roxicet Solution.
When used for long periods of time or at high doses, Roxicet Solution may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Roxicet Solution stops working well. Do not take more than prescribed.
Some people who take Roxicet Solution for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Roxicet Solution, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
Possible side effects of Roxicet Solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dizziness; drowsiness; flushing; light-headedness; nausea; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; hearing loss; mental or mood changes (eg, agitation, anxiety, depression); seizures; severe or persistent constipation; severe or persistent dizziness, headache, or light-headedness; shortness of breath; slow or difficult breathing; stomach or back pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, persistent loss of appetite); tremors; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Roxicet side effects (in more detail)
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold or clammy skin; fainting; limp muscles; loss of consciousness; persistent nausea or vomiting; pinpoint pupils; severe dizziness, drowsiness, or light-headedness; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite); unusual sweating.
Proper storage of Roxicet Solution:
Store Roxicet Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Roxicet Solution out of the reach of children and away from pets.
General information:
- If you have any questions about Roxicet Solution, please talk with your doctor, pharmacist, or other health care provider.
- Roxicet Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Roxicet Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright © 2012 Wolters Kluwer Health, Inc.
More Roxicet resources
- Roxicet Side Effects (in more detail)
- Roxicet Use in Pregnancy & Breastfeeding
- Drug Images
- Roxicet Drug Interactions
- Roxicet Support Group
- 16 Reviews for Roxicet - Add your own review/rating
Compare Roxicet with other medications
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Saturday, 1 October 2011
Cefuroxima IPS Farma
Cefuroxima IPS Farma may be available in the countries listed below.
Ingredient matches for Cefuroxima IPS Farma
Cefuroxime
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Cefuroxima IPS Farma in the following countries:
- Spain
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Closcript
Closcript may be available in the countries listed below.
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- South Africa
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Sunday, 25 September 2011
Miraftil
Miraftil may be available in the countries listed below.
Ingredient matches for Miraftil
Amlexanox
Amlexanox is reported as an ingredient of Miraftil in the following countries:
- Luxembourg
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Friday, 23 September 2011
Duodenal Ulcer Medications
Definition of Duodenal Ulcer: An erosion in the lining of the duodenum (first part of the small intestine, connecting to the stomach). See also gastric ulcer - benign. More...
Drugs associated with Duodenal Ulcer
The following drugs and medications are in some way related to, or used in the treatment of Duodenal Ulcer. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
See sub-topics
Topics under Duodenal Ulcer
- Duodenal Ulcer Prophylaxis (40 drugs)
Learn more about Duodenal Ulcer
Medical Encyclopedia:
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Drug List:
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