Carboplatin

Class: Antineoplastic Agents
VA Class: AN900
CAS Number: 41575-94-4
Brands: Paraplatin

• 
  

  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 Carboplatin

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 paclitaxel^{184 185} 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

Carboplatin 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 Cl_cr <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 Cl_cr <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 Carboplatin

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} Cl_cr 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 Carboplatin

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

Carboplatin 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 (t_½β) for carboplatin and ultrafilterable platinum: 2–3 hours.^{1 43 44}

Terminal elimination half-life (t_½γ) 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, t_½β 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 Compatibility^a

Compatible
Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%
Dextrose 5% in water
Sodium chloride 0.9%
Incompatible
Sodium bica

Transiderm-Nitro 5 and 10

1. Name Of The Medicinal Product

TRANSIDERM NITRO^® 5.

TRANSIDERM NITRO^® 10.

2. Qualitative And Quantitative Composition

Transiderm Nitro 5: Nitroglycerin on lactose 250mg equivalent to nitroglycerin 25mg.

Transiderm Nitro 10: Nitroglycerin on lactose 500mg equivalent to nitroglycerin 50mg.

For excipients see section 6.1.

3. Pharmaceutical Form

Transdermal patch.

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylactic treatment of attacks of angina pectoris, as monotherapy or in combination with other anti-anginal agents.

Transiderm Nitro 5 only : Prophylactic treatment of phlebitis and extravasation secondary to venous cannulation for intravenous fluid and drug administration when the duration of treatment is expected to last for 2 days or longer.

4.2 Posology And Method Of Administration

For dermal administration

Adults:

Angina: Treatment should be initiated with one TRANSIDERM-NITRO 5 patch daily. If a higher dosage is required a TRANSIDERM-NITRO 10 patch may be substituted. The dosage may be increased to a maximum of two TRANSIDERM-NITRO 10 patches daily in resistant cases. TRANSIDERM-NITRO may be given either continuously, or intermittently with a patch off period of 8-12 hours, usually at night, during each 24 hour period. Development of tolerance or attenuation of therapeutic effect commonly occurs with prolonged or frequent administration of all long-acting nitrates. Recent evidence suggests that intermittent therapy with TRANSIDERM-NITRO may reduce the incidence of tolerance.

Prior to the use of intermittent therapy, the clinical benefits to the patients should be weighed against the risks of angina in the patch-free interval. In patients considered to be at risk, concomitant anti-anginal therapy should be implemented (see “Precautions”).

It is recommended that the patch is applied to the lateral chest wall. The replacement patch should be applied to a new area of skin. Allow several days to elapse before applying a fresh patch to the same area of skin. If acute attacks of angina pectoris occur, rapidly acting nitrates may be required.

Phlebitis and extravasation: One TRANSIDERM-NITRO 5 patch is to be applied distal to the site of intravenous cannulation at the time of venepuncture. The patch should be removed after 3-4 days and a new replacement patch applied to a different area of skin. Treatment with TRANSIDERM-NITRO should be discontinued once intravenous therapy has stopped.

Use in the elderly

No specific information on use in the elderly is available; however no evidence exists to suggest that an alteration in dosage is required.

Use in children

There is insufficient knowledge of the effects of TRANSIDERM-NITRO in children and therefore recommendations for its use cannot be made.

4.3 Contraindications

TRANSIDERM-NITRO should not be prescribed to patients hypersensitive to nitrates or to any excipient present in the product. Severe hypotension. Increased intracranial pressure. Myocardial insufficiency due to obstruction (eg in the presence of aortic or mitral stenosis or of constrictive pericarditis).

Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil have been shown to potentiate the hypotensive effects of nitrates and its co-administration with nitrates or nitric oxide donors is therefore contraindicated

4.4 Special Warnings And Precautions For Use

In recent myocardial infarction or acute heart failure, TRANSIDERM-NITRO should be employed only under careful surveillance.

As with all anti-anginal nitrate preparations, withdrawal of long-term treatment should be gradual, by replacement with decreasing doses of long-acting oral nitrates.

The TRANSIDERM-NITRO patch contains an aluminium layer. Therefore the patch must be removed before applying magnetic or electrical fields to the body during procedures such as MRI (Magnetic Resonance Imaging), cardioversion, DC defibrillation or diathermy treatment.

Caution should be exercised in patients with arterial hypoxaemia due to severe anaemia because, in such patients the biotransformation of nitroglycerin is reduced. Similarly, caution is called for in patients with hypoxaemia and a ventilation/perfusion imbalance due to lung disease or ischaemic heart failure.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

The possibility of increased frequency of angina during patch-off periods should be considered. In such cases, the use of concomitant anti-anginal therapy is desirable.

If tolerance to nitroglycerin patches develops, the effects of sublingual nitroglycerin on exercise tolerance may be partially diminished.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant treatment with other vasodilators, calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the blood pressure lowering effects of TRANSIDERM-NITRO.

Concurrent administration of TRANSIDERM-NITRO with dihydroergotamine may increase the bioavailability of dihydroergotamine and lead to coronary vasoconstriction.

The possibility that the ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory drugs might diminish the therapeutic response to TRANSIDERM-NITRO cannot be excluded.

The hypotensive effects of nitrates are potentiated by concurrent administration of PDE5 inhibitors such as sildenafil.

4.6 Pregnancy And Lactation

As with all drugs, TRANSIDERM-NITRO should not be prescribed during pregnancy, particularly during the first trimester, unless there are compelling reasons for doing so.

It is not known whether the active substance passes into the breast milk. The benefits for the mother must be weighed against the risks for the child.

4.7 Effects On Ability To Drive And Use Machines

Postural hypotension has been reported rarely following initiation of treatment with TRANSIDERM-NITRO and care is advised when driving or operating machinery.

4.8 Undesirable Effects

Adverse reactions are ranked in descending order of frequency, as follows: Very common (=1/10); common (=1/100, <1/10); uncommon (=1/1000, <1/100); rare (=1/10,000, <1/1000); very rare (<1/10,000), including isolated reports.

Table 1

Nervous System Disorders:
Common:	Headache
Very rare:	Dizziness
Cardiac Disorders:
Rare:	Tachycardia
Vascular Disorders:
Rare:	Postural hypotension, flushing
Gastrointestinal Disorders:
Very Common:	Nausea, vomiting
Skin and subcutaneous tissue disorders:
Uncommon:	Contact dermatitis
General disorders and administration site conditions:
Uncommon:	Erythema, pruritus, burning, irritation.
Investigations:
Rare:	Heart rate increase

Like other preparations, TRANSIDERM-NITRO may give rise to headache, which is due to cerebral vasodilation and is dose-dependent. Such headaches, however, may regress after a few days despite continuation of the therapy. If they do not disappear, they should be treated with mild analgesics. In cases where headaches are unresponsive to treatment, the dosage of nitroglycerin should be reduced or use of the product discontinued.

Upon removal of the patch, any slight reddening of the skin will usually disappear within a few hours. The application site should be changed on patch replacement to prevent local irritation.

Reflex tachycardia can be controlled by concomitant treatment with a beta-blocker.

4.9 Overdose

Signs:

High doses of glyceryl trinitrate are known to cause pronounced systemic side effects, eg a marked fall in blood pressure and reflex tachycardia resulting in collapse and syncope. Methemoglobinaemia has also been reported following accidental overdosage of nitroglycerin. However, with TRANSIDERM-NITRO, the release membrane will reduce the likelihood of overdosage occurring.

Management:

In contrast to long acting oral nitrate preparations, the effect of TRANSIDERM-NITRO can be rapidly terminated simply by removing the system. Any fall in blood pressure or signs of collapse that may occur, may be managed by general resuscitative measures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: C01DA02

Nitroglycerin relaxes smooth muscle. It acts chiefly on systemic veins and large coronary arteries, with more predominant effects on the former. In angina pectoris the fundamental mechanism of action of nitroglycerin is based on an increase in venous capacitance leading to a decreased return of blood to the heart. Owing to this, preload and hence filling volume diminishes, resulting in a decreased myocardial oxygen requirement at rest and especially during exercise.

In the coronary arterial circulation nitroglycerin dilates extramural conductance and small resistance vessels. It appears to cause redistribution of coronary blood flow to the ischaemic subendocardium by selectively dilating large epicardial vessels and also relaxes vasospasm.

Nitroglycerin dilates the arteriolar vascular bed, as a result of which afterload and left ventricular systolic wall tension decrease, leading to a reduction in myocardial oxygen consumption.

5.2 Pharmacokinetic Properties

Following single application, plasma concentrations of nitroglycerin reach a plateau within 2 hours, which is maintained throughout the day until patch removal. The height of this plateau is directly proportional to the size of the system's drug-releasing area.

The same plasma levels are attained regardless of whether the system is applied to the skin of the upper arm, pelvis or chest. Upon removal of TRANSIDERM-NITRO the plasma level falls rapidly. After repeated application of TRANSIDERM-NITRO no cumulation occurs.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose, silicone oil, silica dioxide, ethylene-vinyl acetate coploymer, silicone-based adhesive (medical adhesive CH15).

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 25ºC.

6.5 Nature And Contents Of Container

Individual patches in a sealed pouch (made of paper/PE/AL/surlyn*). 28 sealed patches in each cardboard container.

* Aluminium 12µm ± 10%, polyethylene 16G/m²± 20%, surlyn 20G/m²± 15%.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Novartis Pharmaceuticals UK Limited

Trading as Ciba Laboratories

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

8. Marketing Authorisation Number(S)

Transiderm Nitro 5 : PL 00101/0464.

Transiderm Nitro 10 : PL 00101/0465.

9. Date Of First Authorisation/Renewal Of The Authorisation

22 June 2004

10. Date Of Revision Of The Text

23 September 2009

Legal Category : P

Celexa

Pronunciation: sye-TAL-oh-pram
Generic Name: Citalopram
Brand Name: Celexa

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Celexa outweigh the risks.

Families and caregivers must closely watch patients who take Celexa. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Celexa is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Celexa is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Do NOT use Celexa if:

• you are allergic to any ingredient in Celexa or to escitalopram


• you have a certain type of irregular heartbeat (long QT syndrome) or uncorrected low blood potassium or magnesium levels


• you are taking escitalopram


• you are taking or have taken linezolid, methylene blue, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), or St. John's wort within the last 14 days


• you are taking astemizole, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine, venlafaxine), sibutramine, other SSRIs (eg, fluoxetine, paroxetine), terfenadine, or tryptophan

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Celexa:

Some medical conditions may interact with Celexa. 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 or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse


• if you have a history of seizures, liver problems, kidney problems, heart problems (eg, heart failure, slow or irregular heartbeat), high blood pressure, stroke, bleeding problems, stomach or bowel bleeding, or metabolism problems


• if you have a condition or take medicine that may increase your risk of low potassium or magnesium levels. Check with your doctor if you are not sure if any of your conditions or medicines may increase this risk


• if you are dehydrated, have low blood volume or low blood sodium levels, or drink alcohol


• if you will be having electroconvulsive therapy (ECT)


• if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

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

• Fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lithium, MAOIs (eg, phenelzine, selegiline), meperidine, methylene blue, metoclopramide, nefazodone, serotonin 5-HT₁ receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, duloxetine, venlafaxine), other SSRIs (eg, fluoxetine, paroxetine), St. John's wort, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur


• Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased


• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased


• Tramadol because the risk of seizures may be increased


• Arsenic, astemizole, cimetidine, halofantrine, nilotinib, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, terfenadine, or vandetanib because the risk of irregular heartbeat may be increased


• Carbamazepine or cyproheptadine because they may decrease Celexa's effectiveness


• Aripiprazole, beta-blockers (eg, propranolol), clozapine, risperidone, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Celexa

This may not be a complete list of all interactions that may occur. Ask your health care provider if Celexa 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 Celexa:

Use Celexa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Celexa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Celexa refilled.


• Take Celexa by mouth with or without food.


• Taking Celexa at the same time each day will help you remember to take it.


• Continue to take Celexa even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Celexa without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Celexa and whenever a change in dose is made.


• If you miss a dose of Celexa, 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 Celexa.

Important safety information:

• Celexa may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Celexa with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are using Celexa.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Celexa; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• One to 4 weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Celexa for longer than prescribed without checking with your doctor.


• Children, teenagers, and young adults who take Celexa may be at increased risk for suicidal thoughts or actions. Watch all patients who take Celexa closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Celexa and a medicine called escitalopram have the same active ingredient. Do not take Celexa if you are also taking escitalopram.


• Celexa may cause an increased risk of severe irregular heartbeat. The risk may be higher with high doses of Celexa. Tell your doctor right away if you develop chest pain; fast, slow, or irregular heartbeat; shortness of breath; dizziness; or fainting. Discuss any questions or concerns with your doctor.


• If your doctor tells you to stop taking Celexa, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Celexa.


• Celexa may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Celexa. Your risk may be greater if you take Celexa with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Celexa. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Use Celexa with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.


• Caution is advised when using Celexa in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.


• Celexa should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Celexa may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Celexa.


• PREGNANCY and BREAST-FEEDING: Celexa may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Celexa while you are pregnant. Celexa is found in breast milk. Do not breast-feed while taking Celexa.

Possible side effects of Celexa:

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; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; light-headedness when you stand or sit up; loss of appetite; nausea; stuffy nose; tiredness; weakness; yawning.

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); absent menstrual period; bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; fainting; fast, slow, or irregular heartbeat; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache; shortness of breath; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.

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: Celexa 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 blue skin or lips; coma; confusion; fast breathing; fast, slow, or irregular heartbeat; memory loss; muscle pain; seizures; severe or persistent dizziness, drowsiness, nausea, or vomiting; tremor.

Proper storage of Celexa:

Store Celexa at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Celexa out of the reach of children and away from pets.

General information:

• If you have any questions about Celexa, please talk with your doctor, pharmacist, or other health care provider.


• Celexa 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 Celexa. 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 Celexa resources

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

• Celexa Prescribing Information (FDA)


• Celexa Consumer Overview


• Celexa Monograph (AHFS DI)


• Celexa Advanced Consumer (Micromedex) - Includes Dosage Information


• Citalopram Professional Patient Advice (Wolters Kluwer)

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Klor-Con M10 Controlled-Release Tablets

Pronunciation: po-TAS-ee-um KLOR-ide
Generic Name: Potassium Chloride
Brand Name: Examples include K-Dur and Klor-Con M10

Klor-Con M10 Controlled-Release Tablets are used for:

Preventing or treating low blood potassium levels in certain patients. Low blood potassium levels may be caused by certain diseases, severe or prolonged episodes of vomiting or diarrhea, certain medicines (eg, corticosteroids, digitalis, diuretics), surgery, or other conditions. It may also be used for other conditions as determined by your doctor.

Klor-Con M10 Controlled-Release Tablets are an electrolyte. It works by providing potassium when you have low levels of potassium in your blood.

Do NOT use Klor-Con M10 Controlled-Release Tablets if:

• you are allergic to any ingredient in Klor-Con M10 Controlled-Release Tablets


• you have high blood potassium levels, severe kidney problems, narrowing of the esophagus because of an enlarged heart, or a blockage, slowing, or paralysis of the esophagus, stomach, or intestines


• you are taking an aldosterone blocker (eg, eplerenone), an anticholinergic (eg, methscopolamine), or a potassium-sparing diuretic (eg, spironolactone, triamterene)

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

Before using Klor-Con M10 Controlled-Release Tablets:

Some medical conditions may interact with Klor-Con M10 Controlled-Release Tablets. 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 adrenal gland, esophagus, kidney, or potassium excretion problems; diabetes; diarrhea; extensive tissue injury (eg, severe burns); heart problems (eg, irregular heartbeat, heart failure, mitral valve replacement); heat cramps; high blood acid levels; high blood pressure; muscle weakness or paralysis; or scleroderma; or if you are dehydrated


• if you are confined to a bed or chair

Some MEDICINES MAY INTERACT with Klor-Con M10 Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aldosterone blockers (eg, eplerenone), angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or potassium-sparing diuretics (eg, spironolactone, triamterene) because the risk of high blood potassium levels may be increased


• Anticholinergics (eg, methscopolamine) because the risk of esophagus, intestinal, or stomach problems may be increased


• Digoxin because the risk of its side effects may be increased by Klor-Con M10 Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Klor-Con M10 Controlled-Release Tablets 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 Klor-Con M10 Controlled-Release Tablets:

Use Klor-Con M10 Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Klor-Con M10 Controlled-Release Tablets by mouth with food or after a meal.


• Take Klor-Con M10 Controlled-Release Tablets with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Klor-Con M10 Controlled-Release Tablets.


• Swallow Klor-Con M10 Controlled-Release Tablets whole. Do not crush, chew, or suck on the tablet before swallowing.


• If you have trouble swallowing the tablet whole, you may break the tablet in half and swallow each half separately with a glass of water. You may also dissolve the tablet in half a glass (4 oz/120 mL) of water. Let the tablet dissolve for 2 minutes, then stir well for half a minute. Swirl and drink all the liquid right away. Add 1 oz/30 mL of water to the glass, swirl, and drink; repeat this 1 more time to ensure you have taken all of the medicine.


• Throw away any unused mixture. Do not store the mixture for future use.


• If you miss a dose of Klor-Con M10 Controlled-Release Tablets, 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 Klor-Con M10 Controlled-Release Tablets.

Important safety information:

• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• If you have trouble swallowing Klor-Con M10 Controlled-Release Tablets, or if it seems to stick to your throat, check with your doctor.


• Lab tests, including blood potassium, kidney function, and electrocardiograms (ECG), may be performed while you use Klor-Con M10 Controlled-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Klor-Con M10 Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Klor-Con M10 Controlled-Release Tablets should be used 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 Klor-Con M10 Controlled-Release Tablets while you are pregnant. Klor-Con M10 Controlled-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Klor-Con M10 Controlled-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Klor-Con M10 Controlled-Release Tablets:

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:

Diarrhea; gas; nausea; stomach discomfort; 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, or tongue); black, tarry stools; chest pain; irregular heartbeat; listlessness; numbness or tingling in your skin, lips, hands, or feet; severe nausea or vomiting; stomach pain or swelling; unusual confusion or anxiety; unusual muscle weakness or paralysis; vomit that looks like coffee grounds; weak or heavy legs.

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: Klor-Con M10 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 chest pain; fast, slow, or irregular heartbeat; limp muscles; listlessness; muscle weakness or paralysis; slow or difficult breathing.

Proper storage of Klor-Con M10 Controlled-Release Tablets:

Store Klor-Con M10 Controlled-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Klor-Con M10 Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Klor-Con M10 Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Klor-Con M10 Controlled-Release Tablets 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 Klor-Con M10 Controlled-Release Tablets. 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 Klor-Con M10 resources

• Klor-Con M10 Side Effects (in more detail)
• Klor-Con M10 Use in Pregnancy & Breastfeeding
• Drug Images
• Klor-Con M10 Drug Interactions
• Klor-Con M10 Support Group
• 0 Reviews for Klor-Con M10 - Add your own review/rating

Compare Klor-Con M10 with other medications

• Hypokalemia
• Prevention of Hypokalemia