Thursday, October 27, 2016

Acetaminophen/Guaifenesin Powder Packets


Pronunciation: a-SEET-a-MIN-oh-fen/gwye-FEN-e-sin
Generic Name: Acetaminophen/Guaifenesin
Brand Name: Theraflu Flu and Chest Congestion


Acetaminophen/Guaifenesin Powder Packets are used for:

Relieving minor aches and pains, headache, and minor sore throat due to colds, and for temporarily reducing fever. It also helps to loosen chest congestion.


Acetaminophen/Guaifenesin Powder Packets are an analgesic and expectorant combination. The analgesic work in the brain to decrease pain and fever. The expectorant thins mucus in the lungs.


Do NOT use Acetaminophen/Guaifenesin Powder Packets if:


  • you are allergic to any ingredient in Acetaminophen/Guaifenesin Powder Packets

Contact your doctor or health care provider right away if any of these apply to you.



Before using Acetaminophen/Guaifenesin Powder Packets:


Some medical conditions may interact with Acetaminophen/Guaifenesin Powder Packets. 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 a history of alcohol abuse or you drink more than 3 alcohol-containing drinks per day

  • if you have liver or kidney problems, hepatitis, or phenylketonuria (PKU), or if you are on a low-salt (sodium) diet

  • if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Acetaminophen/Guaifenesin Powder Packets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Acetaminophen/Guaifenesin Powder Packets

  • Isoniazid because the risk of liver problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Guaifenesin Powder Packets 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 Acetaminophen/Guaifenesin Powder Packets:


Use Acetaminophen/Guaifenesin Powder Packets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Acetaminophen/Guaifenesin Powder Packets by mouth with or without food.

  • Dissolve contents of 1 packet in 8 oz of hot water. Sip while hot. Drink the entire mixture within 10 to 15 minutes.

  • If you are using a microwave, stir before and after heating. Do not overheat.

  • If you miss a dose of Acetaminophen/Guaifenesin Powder Packets 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 Acetaminophen/Guaifenesin Powder Packets.



Important safety information:


  • Acetaminophen/Guaifenesin Powder Packets has acetaminophen and guaifenesin in it. Before you start any new medicine, check the label to see if it has acetaminophen or guaifenesin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Acetaminophen/Guaifenesin Powder Packets may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Guaifenesin Powder Packets. Talk to your doctor before you take Acetaminophen/Guaifenesin Powder Packets or other fever reducers if you drink more than 3 drinks with alcohol per day.

  • Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for sore throat for longer than 2 days unless directed by a doctor.

  • Check with your doctor if pain or cough lasts for more than 7 days, gets worse, or occurs with rash or persistent headache.

  • Do not use Acetaminophen/Guaifenesin Powder Packets for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • Check with your doctor if fever lasts for more than 3 days or if it gets worse.

  • Check with your doctor if redness or swelling is present, or if new symptoms occur.

  • Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

  • Acetaminophen/Guaifenesin Powder Packets may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Acetaminophen/Guaifenesin Powder Packets and need to check your blood cholesterol at home.

  • Do not use Acetaminophen/Guaifenesin Powder Packets in CHILDREN younger than 12 years old without checking with the child's doctor; safety and effectiveness in these 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 Acetaminophen/Guaifenesin Powder Packets while you are pregnant. Acetaminophen/Guaifenesin Powder Packets are found in breast milk. If you are or will be breast-feeding while you use Acetaminophen/Guaifenesin Powder Packets, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Acetaminophen/Guaifenesin Powder Packets:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); dark urine or pale stools; unusual fatigue; yellowing of the skin or eyes.



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: Acetaminophen/Guaifenesin 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 dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.


Proper storage of Acetaminophen/Guaifenesin Powder Packets:

Store Acetaminophen/Guaifenesin Powder Packets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Guaifenesin Powder Packets out of the reach of children and away from pets.


General information:


  • If you have any questions about Acetaminophen/Guaifenesin Powder Packets, please talk with your doctor, pharmacist, or other health care provider.

  • Acetaminophen/Guaifenesin Powder Packets are 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 Acetaminophen/Guaifenesin Powder Packets. 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 Acetaminophen/Guaifenesin resources


  • Acetaminophen/Guaifenesin Side Effects (in more detail)
  • Acetaminophen/Guaifenesin Use in Pregnancy & Breastfeeding
  • Acetaminophen/Guaifenesin Drug Interactions
  • Acetaminophen/Guaifenesin Support Group
  • 0 Reviews for Acetaminophen/Guaifenesin - Add your own review/rating


Compare Acetaminophen/Guaifenesin with other medications


  • Cough
  • Headache
  • Pain


Azo-Septic


Generic Name: phenazopyridine (Oral route)

fen-ay-zoe-PIR-i-deen

Commonly used brand name(s)

In the U.S.


  • Azo-Gesic

  • Azo-Septic

  • Azo-Standard

  • Baridium

  • Phenazo 95

  • Prodium

  • Pyridiate

  • Pyridium

  • RE-Azo

  • Urinary Pain Relief

  • Uristat

  • UTI Relief

Available Dosage Forms:


  • Tablet

  • Kit

Therapeutic Class: Analgesic


Uses For Azo-Septic


Phenazopyridine is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract. It is not an antibiotic and will not cure the infection itself.


In the U.S., phenazopyridine is available only with your doctor's prescription.


Before Using Azo-Septic


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


Although there is no specific information comparing use of phenazopyridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of phenazopyridine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal 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


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.


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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:


  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or

  • Hepatitis or

  • Kidney disease—The chance of side effects may be increased.

Proper Use of phenazopyridine

This section provides information on the proper use of a number of products that contain phenazopyridine. It may not be specific to Azo-Septic. Please read with care.


This medicine is best taken with food or after eating a meal or a snack to lessen stomach upset.


Do not use any leftover medicine for future urinary tract problems without first checking with your doctor. An infection may require additional medicine.


Dosing


The dose of this medicine 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 this medicine. 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.


  • For oral dosage form (tablets):
    • For relieving pain, burning, and discomfort in the urinary tract:
      • Adults and teenagers—200 milligrams (mg) three times a day.

      • Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (about 1.8 mg per pound) of body weight three times a day.



Missed Dose


If you miss a dose of this medicine, 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.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Azo-Septic


Check with your doctor if symptoms such as bloody urine, difficult or painful urination, frequent urge to urinate, or sudden decrease in the amount of urine appear or become worse while you are taking this medicine .


Phenazopyridine causes the urine to turn reddish orange . This is to be expected while you are using it. This effect is harmless and will go away after you stop taking the medicine. Also, the medicine may stain clothing.


For patients who wear soft contact lenses:


  • It is best not to wear soft contact lenses while being treated with this medicine. Phenazopyridine may cause discoloration or staining of contact lenses. It may not be possible to remove the stain.

For diabetic patients:


  • This medicine may cause false test results with urine sugar tests and urine ketone tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

Before you have any medical tests, tell the person in charge that you are taking this medicine. The results of some tests may be affected by this medicine.


Azo-Septic 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 as soon as possible if any of the following side effects occur:


Rare
  • Blue or blue-purple color of skin

  • fever and confusion

  • shortness of breath, tightness in chest, wheezing, or troubled breathing

  • skin rash

  • sudden decrease in the amount of urine

  • swelling of face, fingers, feet, and/or lower legs

  • unusual tiredness or weakness

  • weight gain

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common or rare
  • Dizziness

  • headache

  • indigestion

  • itching of the skin

  • stomach cramps or pain

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: Azo-Septic 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 Azo-Septic resources


  • Azo-Septic Side Effects (in more detail)
  • Azo-Septic Use in Pregnancy & Breastfeeding
  • Azo-Septic Drug Interactions
  • Azo-Septic Support Group
  • 0 Reviews for Azo-Septic - Add your own review/rating


Compare Azo-Septic with other medications


  • Dysuria
  • Interstitial Cystitis


Paraplatin


Generic Name: Carboplatin
Class: Antineoplastic Agents
VA Class: AN900
CAS Number: 41575-94-4



  • Use only under the supervision of a qualified clinician experienced in the use of cytotoxic therapy.1 Use only when adequate treatment facilities for appropriate management of therapy and complications are available.1




  • Dose-related bone marrow suppression may result in infection and/or bleeding.1 Anemia may be cumulative and may require transfusion support.1




  • Vomiting is a common adverse effect.1 201




  • Anaphylactic-like reactions may occur within minutes of administration.1 Administer epinephrine, corticosteroids, and/or antihistamines to relieve symptoms.1




Introduction

Antineoplastic agent; platinum-containing compound.1 2 3 4 5 6 92 93


Uses for Paraplatin


Carboplatin and cisplatin appear to have similar efficacy in the treatment of platinum-responsive ovarian tumors,1 5 9 10 11 12 60 137 184 185 lung cancers,18 29 121 137 and certain head and neck cancers;17 137 carboplatin is less effective than cisplatin in certain testicular cancers.24 78 137 193


Because carboplatin and cisplatin have different toxicity profiles,1 2 3 4 5 8 9 10 11 12 68 carboplatin may be effective in patients with platinum-responsive tumors who are unable to tolerate cisplatin because of renal impairment, refractory nausea, hearing impairment, or neuropathy;4 40 137 cisplatin may be preferred in patients with decreased bone marrow reserve or high risk of sepsis or those requiring anticoagulation therapy.10 137


Ovarian Cancer


Treatment of ovarian cancer (alone and as combination therapy).1 9 29


Combination therapy with platinum-containing agent (carboplatin or cisplatin) and paclitaxel is the preferred regimen for initial treatment of advanced epithelial ovarian cancer; therapy with platinum-containing agent and paclitaxel is superior to therapy with platinum-containing agent and cyclophosphamide.9 29 60 137 139 147 Carboplatin is as effective as but less toxic than cisplatin when used in combination with paclitaxel184 185 or cyclophosphamide.10 11


Carboplatin in combination with docetaxel has been used for the first-line treatment of ovarian cancer and has demonstrated similar efficacy and a different tolerability profile (i.e., more hematologic toxicity but less neurotoxicity) compared with carboplatin in combination with paclitaxel.196


Has been used as a single agent in the first-line treatment of advanced ovarian cancer.9 29 Role remains to be established, but some clinicians consider single-agent carboplatin a reasonable option.29 137 187


Used alone as second-line therapy for palliative treatment of recurrent ovarian cancer in patients with platinum-sensitive disease;1 2 9 nonplatinum-based regimens generally preferred for retreatment of patients with platinum-refractory disease.2 9 60 72


Being studied for use in combination regimens for second-line treatment of advanced ovarian epithelial cancer.9 188 189


Has been used alone or in combination therapy for adjuvant treatment of early-stage ovarian cancer.9 179 180 Survival benefit may be limited to patients whose disease is associated with poorer prognosis.137 179


Lung Cancer


Treatment of small cell lung cancer as a component of combination regimens.3 4 18 19 20 29 75 76


An active agent in non-small cell lung cancer.29 121 132 133 137 152 177 178 197 198


Cervical Cancer


Role in the treatment of cervical cancer remains to be established.157 166 Current evidence supports use of cisplatin in chemotherapy regimens given concurrently with radiation therapy in patients with locally advanced cervical cancer; similar benefit from carboplatin-containing chemotherapy cannot be assumed.157 166


An active agent in the treatment of metastatic or recurrent cervical cancer.29 163 164 165 May be considered an alternative to cisplatin, particularly in patients with nephrotoxicity or neurotoxicity caused by advanced cervical tumor who are not candidates for cisplatin therapy.163 164 165


Head and Neck Cancer


May be useful in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.3 4 5 15 16 17 29 41 128 135 200


Wilms’ Tumor


Has shown activity in the management of Wilms’ tumor.29 65


Brain Tumors


Has been used for palliative treatment of various primary brain tumors.3 29


Has shown activity in the treatment of progressive or recurrent low-grade gliomas in children;29 56 57 responses observed in adults with recurrent glioma, including those who had received previous chemotherapy with nitrosoureas.29 170 171


Has shown activity in the treatment of recurrent medulloblastoma.56 130


Combination therapy with platinum-containing agent (cisplatin or carboplatin) and etoposide is used for treatment of intracranial germ cell tumors.29 169 176


Neuroblastoma


Used (as combination therapy) fortreatment of neuroblastoma.26 29


Testicular Cancer


Cisplatin-based regimen (i.e., cisplatin/etoposide or cisplatin/etoposide/bleomycin) is more effective than carboplatin-based regimen (i.e., carboplatin/etoposide or carboplatin/etoposide/bleomycin) for initial treatment of good-prognosis metastatic nonseminomatous germ cell tumor; generally reserve use of carboplatin regimen for patients who do not tolerate or who refuse cisplatin.24 78 137 193


Limited data suggest that high-dose carboplatin and etoposide may be effective in some patients with relapsed or refractory germ cell tumors.23 30 59


Bladder Cancer


Has been substituted as a less toxic alternative to cisplatin in the treatment of advanced bladder cancer in some patients receiving combination chemotherapy.143 146


Combination therapy with paclitaxel followed by carboplatin is being studied in patients with advanced bladder cancer, including those with abnormal renal function.97 131 168 190


Retinoblastoma


Has been used in combination with etoposide in a limited number of children with recurrent or progressive retinoblastoma.102 106


Breast Cancer


Has been used in a limited number of patients with metastatic breast cancer.199


Endometrial Cancer


Being studied in the treatment of advanced or recurrent endometrial cancer.195


Paraplatin Dosage and Administration


General



  • Consult specialized references for procedures for proper handling and disposal of antineoplastics.1




  • Carboplatin is considered a moderate antiemetic risk antineoplastic (i.e., 30–90% incidence of emesis without antiemetics).201 Antiemetic therapy (e.g., a 5-HT3 receptor antagonist and dexamethasone) is recommended to prevent nausea and vomiting.201 (See Emetogenic Effects under Cautions.)




  • Pretreatment and posttreatment hydration and/or diuresis are not necessary.1 10 11 24 27 37 (See Renal Effects under Cautions.)



Administration


IV Administration


For solution and drug compatibility information, see Compatibility under Stability.


Administer by IV infusion;1 also has been administered intraperitoneally.2 3 4 32 43 47


Needles, syringes, catheters, and IV administration sets that contain aluminum parts which may come in contact with carboplatin should not be used for preparation or administration.1


Reconstitution

Reconstitute vial containing 50, 150, or 450 mg of carboplatin powder for injection with 5, 15, or 45 mL, respectively, of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection to provide a solution containing 10 mg/mL.b


Resulting solutions can be further diluted to concentrations as low as 0.5 mg/mL with 5% dextrose injection or 0.9% sodium chloride injection.b


Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.b


Dilution

May be diluted with 0.9% sodium chloride injection or 5% dextrose injection to a concentration as low as 0.5 mg/mL.1


Rate of Administration

Administer by IV infusion over a period of ≥15 minutes;1 2 4 10 13 25 27 42 also has been administered by continuous IV infusion over 24 hours.1 2 3


Dosage


Base dosage on the clinical, renal, and hematologic response and tolerance of the patient in order to obtain optimum therapeutic response with minimum adverse effects.1 10 11


Initial dosage can be based on body surface area, but dosage may be more accurately calculated using formula dosing methods based on the patient’s renal function.1 81 82 83 84 85 93 107 108 137 (See Methods for Individualization of Dosage under Dosage and Administration.)


When used as a component of a multiple-drug regimen, consult published protocols for the dosage of each chemotherapeutic agent and the method and sequence of administration.


Adults


Ovarian Cancer

Initial Therapy for Advanced (Stage III and IV) Ovarian Carcinoma

IV

Initially, 300 mg/m2 given in combination with cyclophosphamide.1 10 11 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1


Alternatively, calculate dosage using formula dosing methods (see Methods for Individualization of Dosage).1 81 82 83 84 85 93 107 108 137


A course of carboplatin consists of single doses administered once every 4 weeks (or longer if delayed for hematologic toxicity) for a total of 6 cycles.1 10 11 69 70 71


Secondary Treatment of Advanced Ovarian Cancer

IV

Initially, 360 mg/m2 as monotherapy.1 Administer drug once every 4 weeks (or longer if delayed for hematologic toxicity).1 Adjust subsequent dosage according to the patient’s hematologic tolerance of the previous dose (see Dosage Adjustment in the Treatment of Ovarian Cancer); do not administer doses until hematologic function is within acceptable limits.1 137


Dosage Adjustment in the Treatment of Ovarian Cancer










Dosage Adjustment Based on Hematologic Response to Previous Dose

Hematologic Toxicity



Recommended Dosage Adjustment



No hematologic toxicity (platelet count >100,000/mm3 and neutrophil count >2000/mm3)



Increase dosage by 25%1 10 11



Mild or moderate hematologic toxicity (platelet count 50,000–100,000/mm3 or neutrophil count 500–2000/mm3)



No adjustment in dosage1 10 11



Moderate to severe hematologic toxicity (platelet count <50,000/mm3 or neutrophil count <500/mm3)



Decrease dosage by 25%1 10 11 137


Other Malignant Neoplasms

IV

Consult published protocols for dosages and methods and sequences of administration. In general, escalation of dosages above 400 mg/m2 results in substantial hematologic toxicity, but high-dose carboplatin (900–2000 mg/m2) has been used with colony-stimulating factors,40 67 121 autologous bone marrow rescue, and/or peripheral stem cell rescue.28 30 37 40 59 111 137


Methods for Individualization of Dosage

Alternative methods for calculating initial carboplatin dosage have been suggested based on the patient’s pretreatment renal function or pretreatment renal function and desired platelet nadir.1 38 81 82 83 84 85 93 107 108


Calvert Formula

Calculation is based on the patient’s GFR (in mL/minute) and the target AUC (in mg/mL per minute).1 81 82 83 93 137 Dosage is calculated in mg, not mg/m2.1





Calvert Formula for Carboplatin Dosing:



total dose (mg) = target AUC (in mg/mL per min) × [GFR (in mL/min) + 25]


A target AUC of 5 (range: 4–6) mg/mL per minute appears to provide the most appropriate dosage range for use of carboplatin alone in patients previously treated with chemotherapeutic agents.1 82 83 93












Actual Toxicity in Previously Treated Patients1828393

AUC (mg/mL x min)



Percentage of Patients with Grade 3 or 4 Thrombocytopenia



Percentage of Patients with Grade 3 or 4 Leukopenia



4–5



16%



13%



6–7



33%



34%


For patients who previously did not receive chemotherapy, a target AUC of 7 (range: 6–8) mg/mL per minute has been recommended when carboplatin is used alone.82 83 93 Higher target AUCs (e.g., 7.5 mg/mL) also have been used (e.g., when carboplatin was used as a component of high-intensity dosing with paclitaxel and a hematopoietic agent for non-small cell lung carcinoma).121 Subsequent carboplatin dosage has been adjusted according to hematologic tolerance to the previous dose (e.g., reducing the dose by 25% for moderate to severe hematologic toxicity).121


Formula is not sufficiently accurate to determine dosage for children or for adults with severe renal impairment (i.e., GFR <20 mL/minute); therefore, do not use this formula in such patients.83 Consult specialized references for an alternative pediatric formula.83 93 119 120


Chatelut (French) Formula

Method does not require determination of GFR.84 85 93 Dosage is calculated in mg, not mg/m2.84 93





Chatelut (French) Formula for Carboplatin Dosing:



total dose (mg) = target AUC (in mg/mL per min) × carboplatin clearance (in mL/min)


When carboplatin clearance is calculated as follows:





Carboplatin Clearance:



Carboplatin clearance (mL/min) = (0.134 × wt) + ([218 × wt × (1 - {0.00457 × age})] × [1 - {0.314 × gender}] / serum creatinine (mcmol/L)) (where weight is in kg, age is in years, and gender is 0 for males and 1 for females)


Do not use this formula for calculating dosage in pediatric patients or those undergoing hemodialysis.84


Special Populations


Renal Impairment


Reduce dosage in patients with Clcr <60 mL/minute.3 5 38









Dosage Recommendations for Patients with Impaired Renal Function

Baseline Clcr



Initial Dose



41–59 mL/min



250 mg/m2



16–40 mL/min



200 mg/m2


Incidence of severe leukopenia, neutropenia, or thrombocytopenia at these adjusted initial dosages is about 25%.1 Adjust subsequent dosage according to the patient’s hematologic tolerance to the previous dose.1 Experience in patients with Clcr <15 mL/minute is too limited to make dosage recommendations.1


Geriatric Patients


Use of dosing formulas incorporating estimates of GFR to determine dosage recommended in geriatric patients.1


Cautions for Paraplatin


Contraindications



  • History of sensitivity reactions to carboplatin or other platinum-containing compounds (e.g., cisplatin).1




  • Severe bone marrow depression or significant bleeding.1



Warnings/Precautions


Warnings


Highly toxic drug with a low therapeutic index; therapeutic response is not likely to occur without some evidence of toxicity.1 10 11


Hematologic Effects

The major and dose-limiting adverse effects are dose-related hematologic toxicity (thrombocytopenia, leukopenia, neutropenia, and/or anemia).1 2 3 4 5 10 11 27 28 53 56 66 67 79 80 93 121


Myelosuppression appears to be most common and more severe in patients who received prior antineoplastic therapy (especially cisplatin-containing regimens), those concurrently receiving or having recently received other myelosuppressive drugs or radiation therapy, and those with renal impairment.1 3 38 53 66 67 82 83 84 85 93 101 121 137 Patients with poor performance status also appear to be at increased risk for severe leukopenia and thrombocytopenia.1 (See Interactions.)


At usual dosages, thrombocytopenia is more common and pronounced than leukopenia.53 82 93 Thrombocytopenia may be cumulative and occasionally require transfusions.121 Potential for infection.1 10 11


Anemia may be severe or symptomatic (e.g., accompanied by asthenia).1 10 11 Incidence appears to be cumulative.1 93 121 Transfusions may be required, particularly in patients receiving prolonged (>6 cycles) therapy.1 121 137


Monitor hematologic status carefully; perform peripheral blood counts at frequent intervals.1 121


Do not administer to patients with severe bone marrow depression or substantial bleeding.1 In patients who experience myelosuppression, withhold subsequent cycles until neutrophil counts are >2000/mm3 and platelet counts are >100,000/mm3.1


Treatment of severe hematologic toxicity may consist of supportive care, anti-infective agents for complicating infections, blood product transfusions, autologous bone marrow rescue, peripheral stem cell transplantation, and hematopoietic agents (colony-stimulating factors).1 30 40 93 121 137


Emetogenic Effects

Carboplatin is classified as an antineoplastic agent of moderate emetic risk (i.e., 30–90% incidence of emesis without antiemetics).201 Acute vomiting episodes are most common in patients who received prior emetogenic antineoplastic regimens (especially cisplatin-containing regimens) and in those receiving other emetogenic agents concurrently.1 201


Possible reduction in the incidence of nausea and vomiting when given as a 24-hour continuous IV infusion or IV in divided doses over 5 consecutive days rather than as a single IV infusion; however, efficacy of these schedules not established.1


Pretreatment with antiemetics may reduce incidence and severity of emesis; rarely, nausea and vomiting may be refractory to antiemetic therapy.1 3 93 103 136 201 For prevention of acute emesis, ASCO recommends a 2-drug antiemetic regimen consisting of a type 3 serotonin (5-HT3) receptor antagonist and dexamethasone given before carboplatin.201


For the prevention of delayed emesis following administration of carboplatin, ASCO recommends single-agent therapy with dexamethasone or a 5-HT3 receptor antagonist.201


Optimal use of antiemetics for prevention of acute and delayed emesis during early courses of therapy is the most important means for preventing anticipatory vomiting; behavioral modification, hypnosis, and drug therapy (e.g., benzodiazepine with or without conventional antiemetics) also may be useful.136 201


Peripheral Neuropathies

Possible peripheral neuropathies, generally sensory (e.g., paresthesia).1 10 11 93 Increased incidence in patients >65 years of age,1 those receiving prolonged therapy, and/or those who have received prior cisplatin therapy.1 93 121


Preexisting cisplatin-induced peripheral neurotoxicity generally does not worsen during carboplatin therapy.1


Otic Effects

Possible ototoxicity in patients receiving usual dosages of carboplatin in conjunction with cyclophosphamide.1


Concomitant use of ototoxic drugs (e.g., aminoglycosides, furosemide, ifosfamide) may increase risk.93 111 (See Interactions.)


Ocular Effects

Loss of vision (sometimes complete for light and colors) reported in patients receiving higher than usually recommended dosages; improvement and/or total recovery of vision has occurred within weeks following drug discontinuance.1 31


Hepatic Effects

Possible substantial abnormalities in liver function test results in patients receiving high doses (>4 times usual recommended dose) and autologous bone marrow transplantation.1


Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; avoid pregnancy during therapy.1 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1


Embryotoxic and teratogenic in rats.1


Sensitivity Reactions


Hypersensitivity Reactions

Prior exposure to other platinum-containing agents increases the risk for carboplatin-induced allergic reactions, including anaphylaxis.1


Exposure (e.g., industrial) to platinum-containing compounds can cause asthma and immediate and delayed hypersensitivity reactions;33 36 93 consider the possibility that patients with a history of such exposure may be cross-sensitive to carboplatin.36


Observe closely for possible hypersensitivity reactions.1 61 Appropriate equipment for maintenance of an adequate airway and other supportive measures and agents for the treatment of such reactions (e.g., antihistamines, epinephrine, oxygen, corticosteroids) should be readily available when carboplatin is administered.1 61


General Precautions


Mutagenicity and Carcinogenicity

Mutagenic in vitro and in vivo.1


Carcinogenic potential not fully studied; however, drugs with similar mechanisms of action and evidence of mutagenic effects have been reported to be carcinogenic.1 Secondary malignancies reported in patients receiving carboplatin in combination with other agents.1


Renal Effects

Nephrotoxicity is less common and severe than that associated with cisplatin; concomitant IV hydration and diuresis generally not necessary.1 10 11 24 27 37 92 93 However, consider the possibility that nephrotoxicity may be potentiated by other nephrotoxic drugs.1 (See Interactions.)


Specific Populations


Pregnancy

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


Lactation

Not known whether carboplatin or its platinum-containing products are distributed into milk.1 Discontinue nursing during therapy.1


Pediatric Use

Safety and efficacy not established.1


Limited experience in the treatment of germ cell tumors in adolescents ≥16 years of age,24 various brain tumors or neuroblastoma in children 6 months to 19 years of age,26 27 28 56 62 and Wilms’ tumor in children 2–15 years of age.66 79 80


Adverse effects reported to date in children are similar to those reported in adults and include hematologic toxicity (principally thrombocytopenia),27 28 56 66 79 80 adverse GI effects (e.g., nausea, vomiting),27 28 56 66 hypersensitivity reactions (e.g., urticaria, facial swelling, abdominal pain, coryza, cough),62 and hearing loss (particularly at higher than recommended doses in combination with other ototoxic agents).1


Geriatric Use

In clinical trials evaluating carboplatin as combination therapy for ovarian cancer, age was not found to be a factor for survival in patients ≥65 years of age relative to younger adults.1


Possible increased incidence of severe thrombocytopenia and carboplatin-induced peripheral neuropathy in adults ≥65 years of age compared with younger patients.1


Consider increased incidence of decreased renal function in geriatric population (see Geriatric Patients under Dosage and Administration).137


Renal Impairment

Increased risk of severe bone marrow depression in patients with renal impairment; monitor renal function carefully.1 40 82 83 84 85 93 Clcr appears to most accurately reflect kidney function in patients receiving carboplatin.1 40 82 83 84 85 93


Reduce dosage in patients with renal impairment.3 5 38 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


Thrombocytopenia,1 neutropenia,1 leukopenia,1 anemia,1 nausea,1 201 vomiting,1 201 electrolyte abnormalities (hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia),1 alkaline phosphatase elevations.1


Interactions for Paraplatin


Ototoxic Drugs


Hearing loss reported in children receiving carboplatin at higher than recommended doses in combination with other ototoxic drugs.1


Nephrotoxic Drugs


Possible potentiation of renal effects.1


Emetogenic Drugs


Concomitant use with emetogenic drugs or use in individuals who previously received emetogenic therapy is associated with an increased incidence of emesis.1 201


Specific Drugs and Therapies


















Drug or Therapy



Interaction



Comments



Aminoglycosides



Increased risk of nephrotoxicity and/or ototoxicity1



Use with caution1



Antineoplastic agents



Prior antineoplastic therapy may increase risk of bone marrow suppression1



Myelosuppressive agents



Possible potentiation of hematologic toxicity1 3 66 67 101



Monitor carefully; manage dosage and time of administration to minimize additive toxic effects1 93 137



Radiation therapy



Possible potentiation of hematologic toxicity1 3 66 67 101



Monitor carefully; manage dosage and time of administration to minimize additive toxic effects1 93 137


Paraplatin Pharmacokinetics


Complex pharmacokinetics involve the parent compound as well as total platinum (protein-bound and nonprotein-bound platinum) and ultrafilterable platinum (carboplatin and nonprotein-bound carboplatin metabolites).1 2 3 4 43 44


Absorption


Bioavailability


Following IV infusion, peak plasma concentrations of carboplatin, total platinum, and ultrafilterable platinum occur immediately.3 42 44 46


Following intraperitoneal administration, peak plasma concentrations of total platinum, free platinum, and carboplatin are attained within 2–4 hours following instillation.3 4 43 47


Distribution


Extent


Widely distributed into body tissues and fluids, with highest concentrations in the kidney, liver, skin, and tumor tissue;3 43 44 lower concentrations found in fat and brain.3 43 Also distributed into erythrocytes.43 44


Not known whether carboplatin or its platinum-containing products cross the placenta or are distributed into milk.1


Plasma Protein Binding


Carboplatin is not bound to plasma proteins, but degrades to platinum-containing products which rapidly bind to protein.45 49


<24% of platinum is bound to plasma proteins during the first 4 hours after IV administration of carboplatin; within 24 hours, 87% is protein bound.46


Elimination


Metabolism


Metabolic fate has not been completely elucidated.1 3 4 5 6 7 43 No evidence to date that the drug undergoes enzymatic biotransformation; the bidentate dicarboxylate ligands of carboplatin are believed to be displaced by water, forming positively charged platinum complexes that react with nucleophilic sites on DNA.1 3 4 5 6 7 43


Elimination Route


Carboplatin and its platinum-containing product(s) are excreted principally in urine (predominantly via glomerular filtration).1 3 4 43 44


Carboplatin (as ultrafilterable carboplatin) is removed extensively by hemodialysis.54 86


Half-life


Plasma elimination half-lives (t½β) for carboplatin and ultrafilterable platinum: 2–3 hours.1 43 44


Terminal elimination half-life (t½γ) for total platinum: 4–6 days.43 44


Special Populations


In patients with impaired renal function, renal clearance and total body clearance of platinum are reduced.3 4 38 54 In patients undergoing hemodialysis, t½β values for total and ultrafilterable platinum are increased compared with values in individuals with normal renal function.43 54


Stability


Storage


Parenteral


Injection Concentrate

25°C (may be exposed to 15–30°C).1 Protect from light.1


Discard unused solution 14 days after initial entry into vial.1


Discard diluted solutions 8 hours after preparation.1


Powder for Injection

20–25°C; protect from light.b


Reconstituted solutions are stable for 8 hours at room temperature (25°C).b Reconstituted solutions contain no preservatives; discard after 8 hours.b


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Solution Compatibilitya







Compatible



Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%



Dextrose 5% in water



Sodium chloride 0.9%



Incompatible



Wednesday, October 26, 2016

Aztreonam injection


Generic Name: aztreonam (injection) (AZ tree oh nam)

Brand Names: Azactam


What is aztreonam?

Aztreonam is an antibiotic that fights severe or life-threatening infection caused by bacteria.


Aztreonam is used to treat severe infections of the urinary tract, lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.


Aztreonam may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about aztreonam?


You should not use this medication if you are allergic to aztreonam or to a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

Before using aztreonam, tell your doctor if you are allergic to cephalosporins such as Ceftin, Cefzil, Keflex, Omnicef, and others, or if you have liver or kidney disease, or a history of any type of allergy.


Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Aztreonam will not treat a viral infection such as the common cold or flu.


Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking aztreonam and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


What should I discuss with my health care provider before using aztreonam?


You should not use this medication if you are allergic to aztreonam or to a penicillin antibiotic, such as:

  • amoxicillin (Amoxil, Augmentin, Amoxicot, Biomox, Dispermox, Trimox);




  • ampicillin (Omnipen, Principen);




  • carbenicillin (Geocillin);




  • dicloxacillin (Dycill, Dynapen);




  • oxacillin (Bactocill); or




  • penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others).



Also tell your doctor if you are allergic to any other drugs, especially:



  • cephalosporins such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others; or




  • similar antibiotics such as ertapenem (Invanz), imipenem (Primaxin), or meropenem (Merrem).



If you have any of these other conditions, you may need an aztreonam dose adjustment or special tests:



  • liver disease;




  • kidney disease; or




  • a history of any type of allergy.




FDA pregnancy category B. Aztreonam is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Aztreonam can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use aztreonam?


Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Aztreonam is injected into a muscle or a vein. Aztreonam is usually given in a clinic or hospital setting. The medicine may need to be given for several hours or several weeks, depending on how severe your infection is.


You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.


Aztreonam is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.


Use aztreonam for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Aztreonam will not treat a viral infection such as the common cold or flu.


Do not give this medication to another person, even if they have the same symptoms you have. Aztreonam is supplied as a frozen solution in a plastic container. If you use this medicine at home, store the frozen medicine in a freezer. If possible, keep the freezer set at 4 degrees below 0 Fahrenheit or colder.

Thaw the medicine either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly. Aztreonam that is thawed in the refrigerator should be used within 2 weeks.


If you have thawed the medicine at room temperature, you must use it within 48 hours. Once aztreonam has been thawed, it should be clear and appear colorless or slightly yellow. Do not use the medicine if it has changed color or has particles in it, or if the medicine container leaks. Call your doctor or pharmacist for a new prescription.

What happens if I miss a dose?


Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using aztreonam?


Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking aztreonam and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.


Aztreonam side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;




  • confusion, seizure (convulsions);




  • feeling light-headed, fainting;




  • pale skin, easy bruising or bleeding, unusual weakness;




  • fever, chills, body aches, flu symptoms; or




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • mild stomach discomfort;




  • warmth, redness, or tingly feeling under your skin;




  • dizziness;




  • numbness, tingling, or burning pain;




  • mild skin rash or itching;




  • vaginal itching or discharge; or




  • pain, swelling, or irritation around the IV needle.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Aztreonam Dosing Information


Usual Adult Dose for Bacteremia:

2 g IV every 6 to 8 hours

Therapy should be continued for approximately 10 to 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Bacterial Infection:

Moderately severe infections: 1 to 2 g IV or IM every 8 to 12 hours
Severe infections: 2 g IV every 6 to 8 hours (maximum, 8 g/day)

Usual Adult Dose for Cystic Fibrosis:

Inhalation:
Initial dose: 75 mg via nebulizer over approximately 2 to 3 minutes 3 times a day for 28 days; doses should be at least 4 hours apart

Maintenance dose: Administer in alternating cycles of 28 days on and 28 days off.

For patients on multiple inhaled therapies, the following order of administration is recommended: bronchodilator, mucolytics, and lastly, aztreonam for inhalation.

Usual Adult Dose for Febrile Neutropenia:

2 g IV every 6 to 8 hours

Therapy should be continued until the absolute neutrophil count is greater than 500/mm3 and no infection is found or until an adequate clinical response is achieved if a susceptible infection is found and the patient has been afebrile for at least 24 hours. Therapy for neutropenic patients is often required for up to 3 weeks.

Usual Adult Dose for Intraabdominal Infection:

1 to 2 g IV every 8 or 12 hours

For severe or life-threatening infections, a dose of 2 g IV every 6 to 8 hours is recommended. Therapy should be continued for approximately 10 to 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Peritonitis:

1 to 2 g IV every 8 or 12 hours

For severe or life-threatening infections, a dose of 2 g IV every 6 to 8 hours is recommended. Therapy should be continued for approximately 10 to 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Osteomyelitis:

1 to 2 g IV every 8 or 12 hours

For severe or life-threatening infections, a dose of 2 g IV every 6 to 8 hours is recommended. Therapy should be continued for approximately 4 to 6 weeks, depending on the nature and severity of the infection. Chronic osteomyelitis may require an additional 2 months of oral antibiotics.

Usual Adult Dose for Pelvic Inflammatory Disease:

1 to 2 g IV every 8 or 12 hours

For severe or life-threatening infections, a dose of 2 g IV every 6 to 8 hours is recommended. Therapy should be continued until this patient is afebrile and pain-free for 24 to 36 hours.

Usual Adult Dose for Pneumonia:

1 to 2 g IV every 8 or 12 hours

For severe or life-threatening infections, a dose of 2 g IV every 6 to 8 hours is recommended. Therapy should be continued for approximately 21 days, depending on the nature and severity of the infection.

Usual Adult Dose for Pyelonephritis:

1 to 2 g IV every 8 or 12 hours

For severe or life-threatening infections, a dose of 2 g IV every 6 to 8 hours is recommended. Therapy should be continued for approximately 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Skin or Soft Tissue Infection:

1 to 2 g IV every 8 or 12 hours

For severe or life-threatening infections, a dose of 2 g IV every 6 to 8 hours is recommended. Therapy should be continued for approximately 7 days or until 3 days after acute inflammation disappears. For more severe infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

Usual Adult Dose for Urinary Tract Infection:

500 mg to 1 g IV or IM every 8 to 12 hours

Usual Pediatric Dose for Intraabdominal Infection:

7 days or less, 2000 g or less: 30 mg/kg IV every 12 hours
7 days or less, 2001 g or more: 30 mg/kg IV every 8 hours

8 to 30 days, 1199 g or less: 30 mg/kg IV every 12 hours
8 to 30 days, 1200 to 2000 g: 30 mg/kg IV every 8 hours
8 to 30 days, 2001 g or more: 30 mg/kg IV every 6 hours

1 month to 18 years: 30 mg/kg IV every 6 to 8 hours, up to a maximum of 2 g/dose or 8 g/day

Usual Pediatric Dose for Pneumonia:

7 days or less, 2000 g or less: 30 mg/kg IV every 12 hours
7 days or less, 2001 g or more: 30 mg/kg IV every 8 hours

8 to 30 days, 1199 g or less: 30 mg/kg IV every 12 hours
8 to 30 days, 1200 to 2000 g: 30 mg/kg IV every 8 hours
8 to 30 days, 2001 g or more: 30 mg/kg IV every 6 hours

1 month to 18 years: 30 mg/kg IV every 6 to 8 hours, up to a maximum of 2 g/dose or 8 g/day

Usual Pediatric Dose for Bacterial Infection:

7 days or less, 2000 g or less: 30 mg/kg IV every 12 hours
7 days or less, 2001 g or more: 30 mg/kg IV every 8 hours

8 to 30 days, 1199 g or less: 30 mg/kg IV every 12 hours
8 to 30 days, 1200 to 2000 g: 30 mg/kg IV every 8 hours
8 to 30 days, 2001 g or more: 30 mg/kg IV every 6 hours

1 month to 18 years: 30 mg/kg IV every 6 to 8 hours, up to a maximum of 2 g/dose or 8 g/day

Usual Pediatric Dose for Urinary Tract Infection:

7 days or less, 2000 g or less: 30 mg/kg IV every 12 hours
7 days or less, 2001 g or more: 30 mg/kg IV every 8 hours

8 to 30 days, 1199 g or less: 30 mg/kg IV every 12 hours
8 to 30 days, 1200 to 2000 g: 30 mg/kg IV every 8 hours
8 to 30 days, 2001 g or more: 30 mg/kg IV every 6 hours

1 month to 18 years: 30 mg/kg IV every 6 to 8 hours, up to a maximum of 2 g/dose or 8 g/day

Usual Pediatric Dose for Skin and Structure Infection:

7 days or less, 2000 g or less: 30 mg/kg IV every 12 hours
7 days or less, 2001 g or more: 30 mg/kg IV every 8 hours

8 to 30 days, 1199 g or less: 30 mg/kg IV every 12 hours
8 to 30 days, 1200 to 2000 g: 30 mg/kg IV every 8 hours
8 to 30 days, 2001 g or more: 30 mg/kg IV every 6 hours

1 month to 18 years: 30 mg/kg IV every 6 to 8 hours, up to a maximum of 2 g/dose or 8 g/day

Usual Pediatric Dose for Cystic Fibrosis:

Inhalation:
7 years or older:
Initial dose: 75 mg via nebulizer over approximately 2 to 3 minutes 3 times a day for 28 days; doses should be at least 4 hours apart

Maintenance dose: Administer in alternating cycles of 28 days on and 28 days off.

For patients on multiple inhaled therapies, the following order of administration is recommended: bronchodilator, mucolytics, and lastly, aztreonam for inhalation.


What other drugs will affect aztreonam?


The following drugs can interact with aztreonam. Tell your doctor if you are using any of these:



  • amikacin (Amikin);




  • gentamicin (Garamycin);




  • kanamycin (Kantrex);




  • neomycin (Mycifradin, Neo-Fradin, Neo-Tab);




  • streptomycin; or




  • tobramycin (Nebcin, Tobi).



This list is not complete and other drugs may interact with aztreonam. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More aztreonam resources


  • Aztreonam Side Effects (in more detail)
  • Aztreonam Use in Pregnancy & Breastfeeding
  • Aztreonam Drug Interactions
  • Aztreonam Support Group
  • 0 Reviews for Aztreonam - Add your own review/rating


Compare aztreonam with other medications


  • Bacteremia
  • Bacterial Infection
  • Bone infection
  • Cystic Fibrosis
  • Febrile Neutropenia
  • Intraabdominal Infection
  • Kidney Infections
  • Pelvic Inflammatory Disease
  • Peritonitis
  • Pneumonia
  • Pneumonia with Cystic Fibrosis
  • Skin and Structure Infection
  • Skin Infection
  • Urinary Tract Infection


Where can I get more information?


  • Your doctor or pharmacist can provide more information about aztreonam.

See also: aztreonam side effects (in more detail)



Android


Generic Name: methyltestosterone (METH il tes TOS te role)

Brand Names: Android, Methitest, Testred


What is Android (methyltestosterone)?

Methyltestosterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.


Methyltestosterone is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty or other hormonal imbalances. Methyltestosterone is also used in women to treat breast cancer that has spread to other parts of the body.


Methyltestosterone may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Android (methyltestosterone)?


Methyltestosterone can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not use this medication if you are allergic to methyltestosterone, or have prostate cancer or male breast cancer.

Before receiving methyltestosterone, tell your doctor if you have benign prostatic hypertrophy, breast cancer, a bleeding or blood clotting disorder, liver or kidney disease, heart disease, coronary artery disease, congestive heart failure, or a history of heart attack.


To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.


Methyltestosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

What should I discuss with my health care provider before taking Android (methyltestosterone)?


You should not use this medication if you are allergic to methyltestosterone, or have certain conditions. Be sure your doctor knows if you have:

  • prostate cancer;




  • male breast cancer; or




  • if you are pregnant.



Before receiving methyltestosterone, tell your doctor if you are allergic to any drugs, or if you have:



  • benign prostatic hypertrophy (BPH);




  • breast cancer;




  • a bleeding or blood clotting disorder;




  • delayed puberty;




  • liver or kidney disease; or




  • heart disease, coronary artery disease (hardened arteries), congestive heart failure, or a history of heart attack.



If you have any of these conditions, you may need a dose adjustment or special tests to safely take methyltestosterone.


FDA pregnancy category X. This medication can cause birth defects. Do not receive methyltestosterone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are receiving this medication. It is not known whether methyltestosterone passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby. Methyltestosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

How should I take Android (methyltestosterone)?


Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.


Your doctor may occasionally change your dose to make sure you get the best results from this medication.


To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.


Methyltestosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment. Store methyltestosterone at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of methyltestosterone is not expected to cause life-threatening symptoms.


What should I avoid while taking Android (methyltestosterone)?


Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using methyltestosterone.


Android (methyltestosterone) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;




  • swelling, rapid weight gain;




  • increased or ongoing erection of the penis;




  • bone pain, increased thirst, memory problems, restless feeling, confusion, nausea, loss of appetite, increased urination, weakness, muscle twitching; or




  • nausea, vomiting, stomach pain, loss of appetite, and jaundice (yellowing of the skin or eyes).




Women receiving methyltestosterone may develop male characteristics, which could be irreversible if testosterone treatment is continued. Stop taking this medication and call your doctor at once if you notice any of these signs of excess testosterone:

  • changes in menstrual periods;




  • male-pattern hair growth (such as on the chin or chest);




  • hoarse voice; or



  • enlarged clitoris.

Less serious side effects (in men or women) may include:



  • acne, changes in skin color;




  • breast swelling;




  • male pattern baldness;




  • headache, anxiety, depressed mood;




  • mild nausea;




  • numbness or tingly feeling; or




  • increased or decreased interest in sex.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Android (methyltestosterone)?


The following drugs can interact with methyltestosterone. Tell your doctor if you are using any of these:



  • a blood thinner such as warfarin (Coumadin); or




  • insulin or diabetes medication you take by mouth.



This list is not complete and there may be other drugs that can affect methyltestosterone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Android resources


  • Android Side Effects (in more detail)
  • Android Use in Pregnancy & Breastfeeding
  • Drug Images
  • Android Drug Interactions
  • Android Support Group
  • 0 Reviews for Android - Add your own review/rating


  • Android Prescribing Information (FDA)

  • Android MedFacts Consumer Leaflet (Wolters Kluwer)

  • Methyltestosterone Professional Patient Advice (Wolters Kluwer)

  • Methyltestosterone Monograph (AHFS DI)

  • Testred Prescribing Information (FDA)



Compare Android with other medications


  • Breast Cancer, Palliative
  • Delayed Puberty, Male
  • Hypogonadism, Male
  • Postpartum Breast Pain


Where can I get more information?


  • Your pharmacist can provide more information about methyltestosterone.

See also: Android side effects (in more detail)