Bella Capsules

Overview of Bella Capsules

Dosage Strength

  • Bella 1 (Bupropion HCl / Phentermine HCl / Topiramate / Naltrexone HCl / Methylcobalamin) (Slow Release) 65/20/15/8/1mg
  • Bella 2 (Bupropion HCl / Phentermine HCl / Topiramate / Naltrexone HCl / Methylcobalamin) (Slow Release) 65/37.5/15/8/1mg
  • Bella 3 (Bupropion HCl / Caffeine / Oxytocin / Topiramate / Naltrexone HCl / Methylcobalamin) 65mg/20mg/100IU/15mg/8mg/1mg
  • Bella 4 (Bupropion HCl / Phentermine HCl / Topiramate / Naltrexone HCl / Methylcobalamin) (Slow Release) 65/15/15/8/1mg
  • Bella Decaf (Bupropion HCl / Oxytocin / Topiramate / Naltrexone HCl / Methylcobalamin) 65mg/100IU/15mg/8mg/1mg
  • Bella Plus Decaf (Bupropion HCl / Metformin / Oxytocin / Topiramate / Naltrexone HCl / Methylcobalamin) 65mg/250mg/100IU/15mg/8mg/1mg

General Information

Bupropion HCl 
Bupropion is an aminoketone antidepressant that is taken orally. It is not a tricyclic antidepressant and has no relation to any other antidepressant. Bupropion has been well tolerated in patients with tricyclic antidepressant-induced orthostatic hypotension; nonetheless, it has a higher potential for producing seizures than other antidepressants. 1 Bupropion is also approved as a smoking cessation aid and is used off-label for addiction to smokeless tobacco. When paired with behavior modification, the medication has been found to help persons with COPD quit smoking. Bupropion is also used off-label for a variety of neurological/psychological conditions, such as ADHD 2 and neuropathic pain 3. Bupropion hydrochloride was approved by the FDA in December 1985, however it was taken off the market for several years due to concerns about drug-induced seizures. It was relaunched as an antidepressant (Wellbutrin) in July 1989, and later as a sustained-release formulation (i.e., Wellbutrin SR). In May 1997, Zyban, another sustained-release oral dose form, was approved for the treatment of smoking cessation. In 1999, Zyban was given a new indication for use in conjunction with nicotine transdermal systems (NTS) to alleviate the symptoms of smoking cessation. In August 2003, a controlled-release version (Wellbutrin XL) was approved as a once-daily treatment for serious depression in adults. 456 Wellbutrin XL was authorized by the FDA in June 2006 for the prevention of major depressive episodes in people with a history of seasonal affective disorder (SAD). The first prescription medicine approved for patients with a history of SAD is Wellbutrin XL. 7 The FDA approved a once-daily formulation of bupropion hydrobromide (Aplenzin) for depression in April 2008, and Aplenzin was approved for the prevention of seasonal major depressive episodes in patients with SAD in August 2012. Aplenzin is distinct from all previously marketed versions of bupropion hydrochloride salt.

Phentermine HCI
Phentermine is an oral sympathomimetic amine used as an adjuvant in the treatment of exogenous obesity for a brief period of time (e.g., 8—12 weeks). Phentermine has similar pharmacologic effects as amphetamines. The FDA approved phentermine resin complex in 1959, however it is no longer available in the United States. The FDA authorized phentermine hydrochloride in 1973. There was increasing interest in phentermine in combination with another anorectic, fenfluramine, for the treatment of obesity and substance misuse in the mid-1990s, although there is little scientific evidence to support this practice. The FDA issued a ‘Dear Health Care Professional’ letter on July 8, 1997, warning physicians about the development of valvular heart disease and pulmonary hypertension in women receiving the combination of fenfluramine and phentermine; fenfluramine was later withdrawn from the US market in the fall of 1997. The combination of phentermine and other anorectic medications for obesity has not been studied and is not recommended. In May 2011, the FDA authorized Surrenza, an orally disintegrating tablet containing phentermine hydrochloride, for the treatment of exogenous obesity. 8

Topiramate is an antiepileptic medication (AED) that is taken orally and is used to treat partial-onset, generalized primary tonic-clonic seizures as well as as an additional therapy in Lennox-Gastaut syndrome. It is structurally distinct from other AEDs and is produced from the naturally occurring monosaccharide D-fructose. Topiramate, unlike other AEDs, appears to prevent the spread of seizures rather than raising the seizure threshold. Topiramate has several mechanisms of action, which may explain why it is beneficial in patients with diverse seizures who have failed to respond to other medications. Topiramate is still being explored as an add-on therapy and as a monotherapy in a variety of refractory epilepsies in children and adults, including infantile spasms linked with West syndrome. It is also used to prevent migraines in adults and children. Topiramate may have a ‘off-label’ function in the treatment of eating disorders such as binge-eating disorder, tics owing to Tourette’s syndrome or other chronic tic disorders, or drug misuse disorders such as alcohol dependency. 91011121314151617

Naltrexone HCI
Naltrexone is an opiate receptor antagonist that is taken orally. It is generated from thebaine and has a structure that is quite similar to oxymorphone. Similarly to parenteral naloxone, naltrexone is a pure antagonist (no agonist activities are visible), but naltrexone has better oral bioavailability and a significantly longer duration of action than naloxone. In clinical settings, naltrexone is used to help patients who are known opiate abusers maintain an opiate-free condition. Patients who use naltrexone as part of a comprehensive vocational rehabilitation program or other compliance-enhancing program gain the most from it. Unlike methadone or LAAM, naltrexone does not improve medication adherence or avoid withdrawal. Naltrexone has been utilized in the treatment of rapid and ultrarapid detoxification. By providing opiate antagonists, these treatments are intended to precipitate withdrawal. These approaches are expected to reduce the risk of relapse while also allowing for the rapid implementation of naltrexone maintenance and psychosocial assistance. Under general anesthesia or strong sedation, ultrarapid detoxification is conducted. While various studies have been conducted to investigate the role of alternative detoxification procedures, a standardized procedure involving appropriate drugs and dose, safety, and effectiveness in comparison to normal detoxification techniques has not been found. 18 In individuals being treated for alcoholism, naltrexone promotes abstinence, prevents relapse, and reduces alcohol consumption. When used with conventional therapy, naltrexone may only produce a minor improvement in result in some alcoholic individuals. In 1984, the FDA approved naltrexone as an adjuvant treatment for patients who were addicted to opiate agonists. In January 1995, the FDA approved naltrexone for the treatment of alcoholism. In April 2006, the FDA authorized Vivitrol, a once-monthly injectable naltrexone formulation used to assist reduce alcohol cravings. In October 2010, the FDA approved Vivitrol for the prevention of recurrence to opioid dependency following opioid detoxification.

Methylcobalamin, also known as vitamin B12, is a B-vitamin. It can be found in a wide range of foods, including fish, shellfish, meats, and dairy products. Although the terms methylcobalamin and vitamin B12 are used interchangeably, vitamin B12 is also available in the form of hydroxocobalamin, a less widely prescribed medicinal product (see Hydroxocobalamin monograph), and methylcobalamin. Methylcobalamin is used to treat pernicious anemia and vitamin B12 deficiency, as well as in the Schilling test to measure vitamin B12 absorption. Vitamin B12 is a B vitamin that is present in foods such as beef, eggs, and dairy products. Deficiency is uncommon in healthy people; nevertheless, the elderly, devout vegetarians (i.e., vegans), and those with malabsorption issues are more likely to become deficient. Anemia, digestive difficulties, and irreversible nerve damage may ensue if vitamin B12 deficiency is not treated with a vitamin B12 supplement.

Methylcobalamin, the most chemically complicated of all vitamins, is a water-soluble, organometallic molecule with a trivalent cobalt ion bound inside a corrin ring, which, while similar to the porphyrin ring found in heme, chlorophyll, and cytochrome, has two pyrrole rings directly connected. Co is the central metal ion (cobalt). Methylcobalamin cannot be produced by plants or animals; the only species that possess the enzymes required for methylcobalamin production are bacteria and archaea. When opposed to animal tissues, higher plants do not concentrate methylcobalamin from the soil, making them a poor supply of the chemical.

Caffeine is a naturally occurring xanthine derivative that is utilized as a stimulant of the central nervous system and respiratory system, as well as a moderate diuretic. Other xanthine derivatives include theophylline, a bronchodilator, and theobromine, a chemical found in cocoa and chocolate. Caffeine can be found in a variety of beverages including soft drinks. Caffeine is frequently mixed with analgesics or ergot alkaloids to treat migraine and other types of headache. Caffeine is also available without a prescription in medicines advertised to relieve sleepiness or mild water retention. Caffeine was originally licensed for use in a medicine product by the FDA in 1938. It is used as a respiratory stimulant in infants with prematurity apnea, both orally and parenterally. Within 24 hours of dosing, caffeine reduces the frequency of apneic episodes by 30—50%. 19 Caffeine is favored over theophylline in newborns because of its ease of administration, consistent oral absorption, and broad therapeutic window. Cafcit®, a commercial preparation of parenteral caffeine, was licensed by the FDA in October 1999 for the treatment of prematurity apnea after years of only being available under orphan drug status (e.g., Neocaf). The FDA has maintained the approved prescription formulation’s orphan drug status.

Endogenous oxytocin is a hormone released by the hypothalamic supraoptic and paraventricular nuclei and stored in the posterior pituitary. It promotes uterine smooth muscle contraction during pregnancy and causes milk ejection after milk has been produced in the breast. Mating, parenting, and social behaviors have all been linked to oxytocin. Because oxytocin is released during intercourse in both men and women, it is thought to be important in sexual bonding. The hormone is thought to facilitate the emotional attachment between mother and child in addition to assisting nursing and the birthing process. 20 Oxytocin has also been investigated in autism and may be related to the social and developmental deficits associated with the disorder. 21 In clinical practice, oxytocin is most commonly administered to induce and intensify labor and to reduce postpartum bleeding. Intranasal oxytocin formulations, which were used to increase postpartum milk ejection, are no longer made in the United States. The FDA authorized oxytocin in 1962.

Metformin is an oral biguanide anti-diabetic medicine that is comparable to phenformin, which was pulled off the market in the United States in 1977 due to the development of lactic acidosis. However, the chance of this adverse effect is significantly lower with metformin. 22 Metformin’s activities differ from, but complement, those of sulfonylureas and other diabetes treatments. Metformin was reported to produce comparable glycemic control to glyburide in type 2 diabetes. notwithstanding the fact that it resulted in a higher prevalence of stomach issues 23 Metformin has been shown to be effective in the treatment of polycystic ovarian syndrome (PCOS); it lowers blood androgen levels, restores normal menstrual periods and ovulation, and may increase conception rates. 24 Furthermore, limited evidence suggest that it may postpone puberty in girls with precocious puberty and menarche in females with early-normal puberty. 2526 Metformin versus comprehensive lifestyle adjustment has been studied in people with impaired glucose tolerance, and while both lower the incidence of diabetes, lifestyle intervention has a stronger effect. 27 Although lifestyle management is highly beneficial, most patients who utilize it alone fail within the first year of illness. As a result, a joint consensus protocol for the management of type 2 diabetes mellitus developed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes recommends starting metformin with lifestyle modifications as soon as possible after diagnosis. Metformin was selected as the first medication therapy because of its efficacy, safety, and low cost. 282930 Furthermore, in a follow-up study to the UKPDS, researchers discovered that after 10-years of resuming typical care, patients originally randomized to metformin therapy had a 33% relative reduction (RR 0.67, 95 percent CI 0.51—0.89; p=0.005) in the risk of myocardial infarction and a 27% relative reduction (RR 0.73, 95 percent CI 0.59—0.89; p=0.002) in the risk of death from any cause as 31 Metformin was first launched in Europe in the 1950s, but the FDA did not authorize it until December 1994. It is approved as monotherapy or in combination with sulfonylureas, alpha-glucosidase inhibitors, or insulin for type 2 diabetes. In January 2001, the regular-release pills were approved for usage in children over the age of ten. In September 2003, an oral solution (Riomet) was approved. Glucophage XR was approved in October 2000, Fortamet was approved in April 2004, and Glumetza was approved in June 2005, each with its own drug delivery method (see Pharmacokinetics section). When compared to regular-release metformin, extended-release versions provide comparable glucose control but have the advantage of once-daily treatment. Another benefit is a claim of fewer adverse events, specifically gastrointestinal-related adverse events (i.e., flatulence, diarrhea); however, larger trials comparing regular-release metformin to extended-release metformin are needed to confirm these claims, as current trial results are conflicting. 323334


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